Summary of Research and Developments in Macular Degeneration: 2008-2009

by Dan Roberts
June 11, 2009
Laser Rejuvenates the Retina

According to a study announced at the Euretina Congress in May 2008, a laser treatment that “cleans up” Bruch’s membrane may slow down the progression to AMD.
Bruch’s membrane is the tissue that separates the photoreceptor cells (our sight cells) from the nourishing blood vessel layer of the retina. It is through Bruch’s
membrane that the nourishment passes. As we age, however, the membrane can become clogged with debris, inhibiting the process and leading to cell malnutrition. Research at St. Thomas’s Hospital in London has resulted in development of a
therapeutic approach to the problem. The Retinal Rejuvenation Therapy (2RT, Ellex) uses a special green nanosecond pulse laser for “reconditioning” Bruch’s membrane and photo-regeneration. Improvement in visual function has been noted in
humans during preliminary studies. Now, under the guidance of
John Marshall, Ph.D., researchers are setting up a trial to treat the yet-unaffected second eyes of patients who have already lost vision in one eye due to neovascular problems.
The ultimate goal, said Dr. Marshall, is to treat patients in their 40s to keep their eyes young and prevent age-related degenerations of the retina. The treatment is noninvasive and seems to have no adverse effects on the photoreceptors or other parts of the eye.
Good Visual Outcome Following Cataract Surgery

A new study (Nature, Aug 2008) has found good visual outcome following cataract surgery in patients aged 90 and older. The study compared visual outcome of patients with macular degeneration, glaucoma and various other ocular conditions.
Overall visual acuity improvement was 68%, whereas unchanged and worsening rates were 16% each. Results showed that AMD patients showed less improvement than patients with glaucoma or with no visual problems.
The researchers concluded that approximately 70% of very elderly patients can achieve visual acuity improvement following cataract surgery, which rises to 82% in those without accompanying problems. Although patients with AMD show less improvement, 62.5% can still enjoy improvement in visual acuity.
Cataract Surgery Appears Safe

More recent studies, however, are disputing that finding, starting with a report in 2005 that patients who had cataract surgery did not have a higher risk of progressing to more advanced forms of macular degeneration when compared to those who did not have cataract surgery.
This was supported by research published in the February 2009 issue of the Journal of Ophthalmology. Led by Emily Chew, MD (also involved in the 2005 study), the team reported that, after reviewing 11 years of patient follow-up data from the large Age-Related Eye Disease Study (AREDS), “The frequency of neovascular age-related macular degeneration, geographic atrophy, and central geographic atrophy did not differ between patients who had cataract surgery and those who did not. . . [This] may provide some reassurance to patients with age-related macular degeneration who are considering cataract surgery.”
A large comprehensive cohort study reported by J.J. Wang to the 2009 ARVO meeting also confirmed previous studies in finding no significant increased incidence of AMD in eyes having undergone cataract surgery. Dr. Wang stressed, however, that here may be an increase in combination with other AMD risk factors.
New Drug May Reduce Number of Injections for Wet AMD
Regeneron Pharmaceuticals, Inc. and Bayer HealthCare AG Have announced that patients with wet AMD receiving VEGF Trap-Eye in a Phase 2 extension study on an “as needed” dosing schedule continued to show highly significant improvements in retinal thickness and vision gain at 52 weeks. During weeks 12 to 52, patients from all dose groups combined received, on average, only two additional injections. This supports Regeneron’s expectation that, with VEGF-Trap-Eye treatment, patients’ visual acuity will improve over time without the need for monthly intravitreal injections.
Zinthionein in Trials for Treatment of Dry AMD

Zinc has been shown to be an effective antioxidant, which is beneficial to the retina. In July 2008, researchers at Pipex Pharmaceuticals announced success with a complex that evidently results in a more potent antioxidant than zinc alone. This “zincmonocysteine” molecule was developed by combining L-cysteine and zinc in a ratio of 1:1.
Under the commercial name Zinthionein, it was then administered as a 25 mg oral capsule twice a day to 80 test subjects for a period of six months. According to the
phase 2 study results (David Newsome, primary investigator), these patients demonstrated a highly statistically significant improvement in visual acuity, contrast sensitivity and photorecovery time. Continued success in the trials could lead to a new and effective therapy for dry AMD.
More info: www.adeonapharma.com
New Dry AMD Gene Found

As reported in the Aug. 28 online edition of the New England Journal of Medicine, researchers have found a genetic link associated with dry AMD. That’s the good news. The bad news is that siRNA drug therapy may increase the risk for dry AMD in patients who have that genetic variant.
The research team found that the protein TLR3 helps fend off certain viral infections. However, it also increases the risk for dry AMD in subjects taking an experimental anti-VEGF drug called “small interference ribonucleic acid” (siRNA),
which activates TLR3. In fending off viral infections, TLR3 also attacks infected retinal cells, resulting in “a 60 percent spike in retinal cell death among mice and humans
genetically susceptible to developing dry AMD.”
Patients currently involved in the siRNA study (labeled Cand5) sponsored by Acuity Pharmaceuticals should contact their doctors for more information.
“Low Luminance Deficit” May Predict More Severe Vision Loss

It appears that, of people with advanced dry AMD (geographic atrophy) who have a corrected visual acuity of 20/50 or better, those who test more poorly in dim light may progress sooner to more severe vision loss.
A research team under the direction of MD Support advisor Janet Sunness, M.D. (Hoover Services for Low Vision and Blindness, Greater Baltimore Medical Center), found that visual dysfunction under low light can predict subsequent visual acuity loss in late-stage AMD patients.
Of subjects with a visual acuity of 20/50 or more, those who had the worst “low luminance deficit” at the beginning of the study showed a significantly greater loss of visual acuity at two years. 40% of this group showed a loss of three or more lines on the acuity test chart. Identification of this risk factor may provide an important means of predicting the rate of vision loss in patients with advanced dry AMD.
Brain Reorganizes to Adjust for Loss of Vision

A new study from Georgia Tech shows that when patients with macular degeneration focus on using another part of their retina to compensate for their loss of central vision, their brain seems to compensate by reorganizing its neural
connections. The study appears in the December edition of the journal Restorative Neurology and Neuroscience.
Eric Schumacher, assistant professor in Georgia Tech’s School of Psychology, said, “Our results show that the patient’s behavior may be critical to get the brain to reorganize in response to disease. It’s not enough to lose input to a brain region for that region to reorganize; the change in the patient’s behavior also matters.”
In this case, that change of behavior comes when patients with AMD make up for this loss by focusing with other parts of their visual field.
Schumacher and his research team found that when patients visually stimulated the preferred retinal locations, they increased brain activity in the same parts of the visual cortex that are normally activated when healthy patients focused on objects in their central visual field. They concluded that the brain had reorganized itself.
While there is evidence with other tasks that suggests that the brain can reorganize itself, this is the first study to directly show that this reorganization in patients with retinal disease is related to patient behavior. The research group is currently studying how long this reorganization takes
and whether it can be fostered through low-vision training in eccentric viewing.
The Latest on AREDS

Emily Chew, M.D., reported to the ARVO meeting that genotypes determine the extent of protection offered by the AREDS formula. In the ARED study, people with genotype TT showed the greatest protective effect, while those with genotype CC
showed the greatest risk of progression to advanced geographic atrophy.
Dr. Chew said that patients can probably discontinue the AREDS supplements once the advanced wet stage is reached. Patients with non-central geographic atrophy (dry MD) and no choroidal neovascularization (vessel growth and leakage) should continue.
Finally, Dr. Chew on the new AREDS2 study. This is a followup to the original “Age-Related Eye Disease Study” completed in 1998. That study resulted in most doctors recommending the AREDS formula to patients in the intermediate stage of
AMD, in order to slow progression to the advanced stage. The formula contains vitamin C, 500 mg; vitamin E, 400 IU; beta carotene, 15 mg; and zinc, 80 mg. The new formula now being tested is slightly altered, with less zinc, no beta-carotene, and the addition of lutein, zeaxanthin and omega-3 fatty acids DHA and EPA. The purpose is to see if the new formula will be even more effective. The AREDS2 cohort has been fully recruited, and first results are expected in 5 years.
PDT Still a Viable Treatment in Some Cases

Several years ago, photodynamic therapy (PDT) was the most effective treatment for wet AMD, but it has been mostly replaced by the new antiangiogenic drugs. This treatment involved injection of the light-activated drug Verteporfin (Visudyne) into a vein, followed by targeting the leaking blood vessel with a low power laser. This destroyed the vessel and stopped the leakage, but it also caused some residual
damage to surrounding cells after repeated procedures. Still, PDT is used in some cases where the vessel’s location is not close to the center of the macula and quick action is necessary.
Now, a new less damaging and more effective approach called “Targeted” Photodynamic Therapy (TPT) is being studied. According to Dr. R.A. Adelman in a report to the ARVO meeting, a protein called Factor VII is conjugated with Verteporfin.
Intravitreal injection of the compound in a rat model with choroidal neovascularization showed efficacy at 1/10th the usual dose of Verteporfin and 3x better visual function
after lasering. This proved to be more effective and safer for surrounding cells than standard PDT at a significantly lower dose.
The Latest on Lucentis

Lucentis, developed by Genentech Pharmaceuticals, is one of two FDA approved drugs used in treatment of wet AMD. The other is Macugen, which has been shown to be less effective. Avastin is also being used off-label with reported success, but it has
yet to be shown to be safe and efficacious in large studies.
Three followup studies of Lucentis, called HORIZON, EXCITE and SUSTAIN, were reported on at the ARVO meeting by Drs. M. Singer, C. Simader and F.G. Holz.
The HORIZON study, which ended in Sep 2008, followed Genentech’s Marina, Anchor and Focus trials, all of which were followup studies of Lucentis. The results showed that the rate of ocular and nonocular adverse events was low, repeated
injections were well tolerated after 4 years, and delay in initial treatment resulted in a higher loss of vision.
The EXCITE study compared quarterly treatment with monthly treatment using Lucentis. Best corrected visual acuity and retinal morphology were found to be better with a monthly regimen of injections.
The SUSTAIN study analyzed safety of monthly dosages of 0.3 and 0.5 mg. Lucentis was found to be safe and effective, no matter what the amount of dosage or the interval of time between treatments.
Since monthly treatment on an as-needed basis at 0.5 mg has been found to be most effective, more refined testing (eg. higher resolution OCT) will be needed in order to better judge if and when patients need to be retreated.
Bilateral Injections Appear Safe

Dr. KariAnne Galler reported to the ARVO meeting that there is no particular increase in risk for patients with bilateral macular degeneration treated with bilateral injections
of anti-VEGF drugs. Also, there is a strong patient preference for the ease and convenience of having bilateral rather than unilateral injections.
Obama Lifts Limits on Stem Cell Research

President Obama has lifted the Bush administration’s limits on human embryonic stem cell research. Mr. Obama announced the decision on March 9, saying he hoped Congress would follow with bipartisan legislation that would ease the existing restrictions even more.
The president acknowledged that studying stem cells extracted from human embryos is deeply divisive, but he said the majority of Americans “have come to a consensus that we should pursue this research; that the potential it offers is great,
and with proper guidelines and strict oversight the perils can be avoided.”
First Human Embryonic Stem Cell Study Approved By FDA

Geron, a biotech company, has announced that the federal government will allow the world’s first test in people of a therapy derived from human embryonic stem cells. Until now, federal financing for research on embryonic stem cells has been restricted, because creation of the cells entails the destruction of human embryos.
The intended reversal of this policy by the newly-elected administration may or may not have influenced this recent decision.
Geron will enroll paralyzed patients who can be treated within 2 weeks of their injury. The subjects will then be evaluated for at least one year, after which the company hopes to increase the dose and expand the number of participants.
This release of government funding is expected to set a precedent for more stem cell research in the low vision field. For more information about the research to this point, see “The First Seven Years: An Overview of Stem Cell Transplantation Research for Treatment of Retinal Disease” on this site.
Stem Cell Therapy Presents Challenges

A special interest group discussed the challenges of bringing stem cell therapy to the patients. The topics were addressed by P.J. Coffey (Institute of Ophthalmology, University College, London), H. Klassen (Univ. of California, Irvine), and M. Friedlander (Scripps Research Institute).
The topics of discussion were:

  • Ways of getting the cells to the site of action, either by surgical insertion or injection into the vitreous fluid.
  • The safety of the procedure
  • The length of time it will take for the procedure to have an effect
  • The question of whether the body will reject the implants
  • Sources of stem cells

To summarize:
Dr. Coffey stated that the goal of The London Project at Moorfields Hospital is to reconstruct the macula by repopulating the retinal pigment epithelium (RPE) to nourish the photoreceptors. This has been accomplished successfully by macular translocation and RPE transplantation. The problem, however, is that these procedures take several hours and at least two separate visits to the clinic. The solution, said Dr. Coffey, is to implant (by injection) a permanent artificial membrane of human embryonic cells. This has been shown to stop pig photoreceptors from dying, and there has been no immunological response (i.e. rejection) so far.
Dr. Klassen discussed culture and transplantation of retinal progenitor cells (RPC), which he says is a key developmental stage in the pathway to replicating rod photoreceptors, even for Müller and ciliary cells. RPCs have been obtained from
animals and encouraged (by adding a growth factor) to differentiate into photoreceptors. They have been well-tolerated in the treated retinas. He added that human RPCs have been successfully used in China to repair the optic nerve.
Dr. Friedlander discussed adult stem cell based therapies. Sources for such cells are the cornea, bone marrow, peripheral blood, spinal cord blood, skin, hair and dormant stem cells. He introduced a new strategy involving rebuilding retinal vessels instead of inhibiting neovascularization. He described how this “vasculotrophic rescue” can be done with bone marrow derived stem cells.
FDA Panel Recommends Approval of IMT

On March 27, 2009, the FDA’s ophthalmic device panel recommended approval of Vision Care Ophthalmic Technology’s implantable miniature telescope (IMT) for patients with advanced stage AMD. After 5 years of trials and a prior unsuccessful submission to the panel, the IMT has now met all requirements for safety and efficacy.
The FDA usually follows the recommendations of an advisory panel, but is not required to do so. The panel recommended approval of the device with conditions including post-approval surveillance and labeling suggestions. The panel decision
was reached by a vote of 8 to 0.
Allen W. Hill, CEO of VisionCare, said “We are pleased with the panel’s recommendation for approval and will work closely with FDA to address the approval conditions. We look forward to providing the ophthalmic community a new treatment option to improve vision and quality of life for patients with untreatable, end-stage agerelated macular degeneration.”
I spoke to the panel shortly before the vote. I told them that, until now, nothing has offered long-term vision restoration for people in the advanced stage of the disease.
That stage has traditionally been one of transition to nonvisual skills such as cane use and Braille. With the IMT, it may be possible for some of us to put that off indefinitely, and that gives us one more cannon to fire.
For more information on the research, visit VisionCare’s website at www.visioncareinc.net or call (408) 872-0526.
Seeing With Your Tongue

One of the most interesting developments reported at Vision 2008 in Montreal was new device called BrainPort, which (according to the abstract) enables perception of visual information using the tongue and camera imaging system as a paired substitute for the eye.
Visual information is collected from a head mounted image sensor and translated into electrical patterns displayed on the surface of the tongue. The system has tested favorably on subjects with no vision, and it is now being adapted to assist individuals with macular degeneration and related diseases.
The long term goal is to develop a fully portable, unobtrusive
device that will track with the userís gaze point, capture information centered in the area of vision loss, and display the information on the tongue. This device will “fill in”
the area of vision loss, will be compatible with other vision-assisting devices, will not be surgically invasive, and will be easily customizable and upgradeable. Developers are hoping to have the BrainPort commercially available within 2
years. Here is where you can read more about it:
vision.wicab.com/technology
DIET & NUTRITION
Statins May Hasten Onset of Wet AMD

What effect do cholesterol-lowering drugs have on the retina? A pilot study in 2006 found “that treatment with simvastatin increased blood-flow velocity in the retinal arteries and veins and decreased intraocular pressure. (Nagaoka T et al. Arch Ophthalmol 2006; 124:665-670.)
This study supports the thinking that increased blood flow is generally beneficial to the retina. Recent research, however, has shown that taking statins to lower cholesterol levels might hasten the onset of wet AMD in people who are already
affected by the dry form. The abstract for this study may be read on the Web at www.tinyurl.com/5ksj6a.
Considering the proven beneficial effects of drugs like simvastatin for people with circulatory problems and high cholesterol, it would be wise to keep this information in mind, but it would not be wise to stop taking them altogether without professional consultation. Until researchers have sorted out the facts, a patient’s decision should be based upon individual circumstances and discussed with professional care providers.
Vitamin C May Lower Statin Levels

A UC Berkeley study, led by Gladys Block, PhD, suggests that 1,000 mg of daily supplemental vitamin C can lower concentrations of C-reactive protein (CRP), the marker associated with systemic inflammation. (Free Radical Biology and Medicine, Jan. 1, 2009). It suggests that a daily dose of supplemental vitamin C can lower CRP levels in healthy, non-smoking adults in two months.
Gladys Block and her staff found that for people with elevated CRP levels, the amount of CRP reduction achieved by taking vitamin C in this particular study is comparable to that in many statin studies.
A multinational clinical trial led by researchers at Harvard Medical School (the Jupiter Trial), found that among people who had high levels of CRP at baseline, levels of CRP were 37 percent lower in the subjects who took statins compared to those who took the placebo.
In the UC Berkeley study on vitamin C, participants who started out with CRP levels greater than 2 milligrams per liter had 34 percent lower levels of CRP with vitamin C compared with a placebo after two months.
“This is clearly a line of research worth pursuing,” said Dr. Block. “It has recently been suggested by some researchers that people with elevated CRP should be put on statins as a preventive measure. For people who have elevated CRP but not elevated LDL cholesterol, our data suggest that vitamin C should be investigated as an alternative to statins, or as something to be used to delay the time when statin use
becomes necessary.”
The benefits to the consumer are that Vitamin C is considerably less costly, and it does not carry the risk of serious side-effects associated with statins.
Source: Ellen Troyer, MT, MA (Chief Research Officer, Biosyntrx .com
Excess Weight Contributes to Mortality

by Ellen Troyer, MT MA
Biosyntrx Chief Research Officer
Excess weight is an epidemic in the United States. There is strong scientific agreement that excess weight (BMI over 25) contributes to overall mortality. It also significantly increases the risk of serious degenerative diseases, including cataracts, macular degeneration, glaucoma, and diabetic retinopathy.
The National Center for Health Statistics estimates that 65% of the U.S. population is overweight, with 34% of the population being clinically obese. Scientists have also identified the significantly increased risks associated with excess weight for 20 other diseases or conditions. According to the U.S. Surgeon General report, excess weight and obesity are responsible for 300,000 deaths every year in the U.S.
Vitamins B-6, B-12 and Folic Acid May Protect Against AMD

Ellen Troyer, MT MA
Biosyntrx Chief Research Officer
A recent study suggests that a combination of vitamin B-6, vitamin B-12 and folic acid may protect women against age-related macular degeneration. Epidemiologists at Harvard Medical School and Women’s Hospital in Boston analyzed data collected as part of a large trial originally designed to test the effects of other vitamins on women with heart problems. All subjects were permitted to take multivitamins with B-6, B-12 and folate up to, but not exceeding, recommended
daily allowances (RDAs). Those getting the B-6, B-12 and folate supplements received much larger amounts.
After 7.3 years, researchers found 82 cases of age-related macular degeneration among women taking placebos and only 55 cases in the women receiving the high-potency B vitamin supplements. While an explanation for the apparent protection from macular degeneration remains unknown, it is known that folate, B-6 and B-12 can drive down blood concentrations of homocysteine, a methionine metabolism by-product compound
suspected of damaging blood vessels.
On the surface this study seems to be very positive, but it raises some concerns about the folic acid dosage. Excessive supplemental folic acid can mask or obscure fairly common vitamin B-12 deficiencies in older people. This can result in an increased risk of progressive, unrecognized neurological damage. Dosage of supplemental folic acid over 1 mg per day has also been associated with impaired gastrointestinal absorption of zinc in some cases.
It’s good to remember that more is not always better.
Too Much Red Meat?

Research* has revealed that a diet high in red meat may increase one’s risk of developing AMD, while consumption of chicken may lower the risk.
Researchers followed 6,734 persons aged 58-69 years, from 1990 through 2006. Final data showed that higher red meat intake was positively associated with early AMD. The odds ratio for consumption of red meat 10 or more times a week versus less than 5 times a week was 1.47. Conversely, consumption of chicken 3.5 or more times a week versus less than 1.5 times a week was inversely associated with late AMD. The team concluded that different meats may differently affect AMD risk and may be a target for lifestyle modification.
Inflammation is being identified as the main culprit in the development of AMD, and cholesterol is inflammation’s “partner in crime.” Fatty red meat is a major source of cholesterol, while lean red meat actually produces less than the body does by itself.
High quantities of red meat, therefore, may be an important risk factor, but it appears that we can sidestep the problem by consuming less, and only the leanest cuts.
*Red Meat and Chicken Consumption and Its Association With Age-related Macular Degeneration, Elaine W.-T. Chong, et al (American Journal of Epidemiology, November 25, 2008).
Occurrence of AMD Declining

A new study reports a lower 5-year incidence of early AMD in patients born or examined more recently, compared to similarly aged persons born or examined in an earlier period.
The study included 2,968 participants with early AMD and 3,588 participants with late stage AMD, all of whom were examined at 5-year intervals between 1988 and 2005 as part of the Beaver Dam Eye Study.
The investigators cannot yet explain the results. Improvements in health care and lifestyle over the previous 15 years do not explain the decline, but other factors might. These include other exposures earlier in life (e.g., infectious disease
outbreaks such as the flu pandemic of 1918), dietary restrictions specific to a period (e.g., the Great Depression), or other unmeasured factors.
Personally, I would like to think that greater health conciousness and awareness of the risk factors for AMD have made a positive contribution. We can play a part in maintaining that decline by continuing to educate ourselves and others about how we may fend off this disease, at least until these promising cures we hear about reach our hospitals and clinics.
Thank you for reading this summary. The fact that it has been lengthy is testament to the encouraging work being done in the field, and let’s continue to remain positive about the positive outcomes, whether for our benefit or for the benefit
of those who follow us.

Summary of Research and Developments in Macular Degeneration: 2007-2008

Compiled and edited by Dan Roberts
JUNE 2007
Omega-3 Proving to be Beneficial on Several Fronts
Recent studies have shown that Omega-3 fatty acids and fish consumption may reduce the risks of age-related macular degeneration (AMD), Alzheimer’s disease, inflammation and depression.
The Age-Related Eye Disease Study (AREDS) Research Group showed that dietary total Omega-3 and docosahexaenic acid (DHA), a fatty acid, are beneficial to people with AMD. The study further verified what leading nutritionists have been saying for years: that several servings of the right kinds of fish per week are good for the retina.
Fish with the highest amount of Omega-3 are wild chinook or sockeye salmon, European anchovies, Atlantic/Pacific herring, small Atlantic/Pacific mackerel, black and red caviar, shrimp and Pacific sardines. Omega-3 can also be obtained from freshly-ground flaxseed or in stable, mercury-free fish oil supplements. Up to 200 mg of supplementary DHA is recommended for people who do not get enough fish in their diet.
Another study suggests that DHA may help prevent the accumulation of tau, a protein thought to be associated with brain lesions in Alzheimer’s disease. Researchers from the University of California Irvine fed genetically modified mice different ratios of Omega-3 fatty acids, DHA and Omega-6 linoleic acid. Omega-6, which initiates the body’s beneficial inflammation response to disease or injury, is already plentiful in a normal diet, and too much of it can lead to uncontrolled inflammation–thought to be a major cause of AMD.
Mice that were fed a higher amount of Omega-3 and DHA than Omega-6, and mice that were fed only DHA, had lower levels of tau and a peptide called beta-amyloid (a constituent of amyloid plaques in the brains of Alzheimer’s patients). The study also showed that DHA works better alone than in combination with Omega-6 fatty acids.
Some types of fish contain high amounts of Omega-6 and should, therefore, be avoided. Fish that contain dangerously high amounts are grouper, halibut, pompano, catfish, and Atlantic salmon.
Omega-3 also seems to help lower levels of depression. Researchers at Ohio State University in Columbus found that people who consumed much more Omega-6 than Omega-3 fatty acids reported more symptoms of depression.
All of these findings give further support to the current AREDS2 research, which is looking at adding Omega-3 fatty acid DHA to the original formula. Meanwhile, strong evidence suggests that it should be an integral part of everyone’s diet, either through food or through supplementation.
(Some nutritional information in this article was provided by Ellen Troyer, MT, MA, Executive Vice President & Chief Research Officer, Biosyntrx.com.)
You May Need Vitamin D
If you are protecting your retinas by avoiding direct sunlight, you may also be depriving yourself of a natural source of vitamin D. This is the vitamin which allows your body to absorb enough calcium for strong bones. It is also important to protect us against muscle weakness and possibly a risk of breast, prostrate, and colon cancer.
In a Reader’s Digest article (“Custom-Fit Vitamins,” by Lisa Davis, November 2001), endocrynologist Michael Holick from Boston University recommended that adults expose their hands, arms, and faces to the sun for at least fifteen minutes three times a week. For people with macular degeneration, this would, of course, require wearing 100% UV protective sunglasses. If, however, this kind of exposure concerns you, then the alternative is to take at least 400 IU of vitamin D daily, which can be gotten from a multi-vitamin. If you are over 70, at least 600 IU is recommended, which means taking an additional supplement.
A paper published in the May 2007 issue of Archives of Ophthalmology confirmed that supplemental vitamin D may was inversely associated with early AMD, but only in individuals who did not consume milk daily. The researchers assessed 7,752 individuals, 11% of whom had AMD. They also found that levels of serum vitamin D were inversely associated with early AMD but not advanced AMD.
Good News For Chocolate Lovers, Cautionary Advice for Wine Drinkers
A report published in the December 2003 issue of Journal of Agricultural and Food Chemistry announced that cocoa has more antioxidant power that wine or tea. We have been told that red wine and green tea are beneficial for our retinas, but it looks like we should be drinking cocoa, too.
Cocoa has almost twice the antioxidant power of wine, 2-3 times that of green tea, and 4-5 times that of black tea. Scientist Chang Yong Lee headed up the study under the auspices of Cornell University in New York and Seoul National University in Korea. In an interview with a reporter for the AARP Bulletin (January 2004), Dr. Lee suggested a cup of hot chocolate in the morning, a cup of green tea in the afternoon, and a glass of red wine in the evening. This combination would satisfy our daily antioxidant requirement.
But remember: all things in moderation. Michael Holick (see above article) points out that people who drink more than two glasses of wine daily could be doubling their risk of colon cancer, and women who drink one or two glasses of wine daily may raise their chances of developing breast cancer by up to forty per cent. Since a glass of red wine daily has been shown to be beneficial to the retina, its negative effects may be lessened by an intake of 400 to 600 mcg of vitamin B (folic acid). This is the equivalent of four to nine glasses of orange juice per day or two cups of boiled spinach, or it can be taken in a multivitamin.
JULY 2007
Stem Cell Research Continues to Make News
In June 2007, Advanced Cell Technology announced successful production of a human embryonic stem cell line (hESC) without destroying an embryo. In 2006, ACT announced the development of the technique for harmlessly removing a single cell (a blastomere) from an eight-cell human embryo, and now they have succeeded in reality.
On January 7, 2007, researchers at the Institute for Regenerative Medicine at Wake Forest University School of Medicine discovered another potential source of embryonic stem cells in the amniotic fluid that protects babies in the womb. These cells appear to be almost as malleable as those in the embryo itself, and the advantage would be that harvesting them would not harm the embryo. Several more years of study are needed to assess their application in humans.
Other research is taking place in the United Kingdom at the University College London, Moorfields Eye Hospital and Sheffield University, in a cooperative effort called the London Project to Cure Blindness. Doctors at Moorfields have had some success with human subjects using adult stem cells from the patients’ own eyes. Embryonic cells, however, have been shown to be more malleable and easier to transplant than adult stem cells. Laboratory-grown cells from the blastocyst of a 5-day old embryo require only one injection (a 45-minute procedure), whereas the Moorfields experiments have taken two hours and two surgical procedures. This protocol would be very expensive and impractical in general practice, so the researchers at the University of Sheffield are using embryos, which will take a little longer to get into human trials.
It is important to remember that stem cell transplantation is a treatment, not a cure. It is definitely promising, but if the cause of the disease is not eliminated, even replacement cells can eventually be affected. The cure will likely come from gene replacement, and that is a few more years down the road.
AUGUST 2007
New Radiation Treatment for Wet AMD
NeoVista, Inc. announced on June 17, 2007 the official commencement of the CABERNET (Cnv secondary to Amd treated with BEta RadiatioN Epiretinal Therapy) clinical trial for the treatment of subfoveal choroidal neovascularization associated with wet AMD. The proprietary Epi-Rad90™ Ophthalmic System, developed by NeoVista, is being utilized in the CABERNET clinical trial, including sites in the United States, Europe, Israel and South America. Learn more about the CABERNET trial at www. mdsupport.org/library/radiation2.html.
C3 Gene Variant Increases Risk of AMD
Researchers have found a gene variant that can more than double the risk of age-related macular degeneration (AMD).
The researchers based their findings on studies of 847 patients with who were compared with 701 unaffected people. They found that a variant in the complement C3 gene influenced the risk of developing AMD. For the 30% of the population who carry one copy of the so-called “fast” variant the risk of AMD was increased by 70%, and for the 4% of people with two copies of the “fast” variant the risk of AMD was more than doubled. The “fast” variant in the C3 gene increases the risk of both the wet and dry forms of the disease.
The complement C3 gene has a central role in the immune system. The results of this research provide strong evidence that inflammation is an important part of the disease process in AMD. This research was reported in the July 2007 New England Journal of Medicine.
NOVEMBER 2007
Study Suggests Antioxidants May Not Prevent AMD Onset
A meta-analysis of published studies has found that vitamin A, vitamin C, vitamin E, zinc, lutein, zeaxanthin, beta carotene, beta cryptoxanthin, and lycopene will not prevent the onset of early AMD.
The report, published in the October issue of the British Medical Journal concluded that “there is insufficient evidence to support the role of dietary antioxidants, including the use of dietary antioxidant supplements, for the primary prevention of early AMD.” MD Support clarifies that this is referring to primary development of the disease, not slowing down of the progression of the disease once it has developed. The results of the Age-Related Eye Disease Study (AREDS) still stand: patients with advanced cases of dry AMD can moderately lower the risk of developing the more severe wet form of the disease and preserve vision by taking a daily dose of antioxidant vitamins and zinc.
In opposition to the conclusions of the meta-analysis, leading nutritionists argue that a discussion of disease prevention is much more complex than looking at the effect of a few antioxidants out of the entire spectrum of nutrients affecting the body’s development and maintenance. We will hear more on this side of the issue from nutritionist Ellen Troyer at our next session.
DECEMBER 2007
Endostatin Joins List of Experimental Anti-Angiogenic Drugs for Wet AMD
Endostatin is an experimental drug derived from type XVIII collagen. It is currently being tested to stop cancer in people by restricting the formation of abnormal blood vessels supplying blood to tumors. Past research (J Folkman, 2006) has shown that it may restrict the formation of abnormal blood vessels by interfering with growth factor proteins such as vascular endothelial growth factor (VEGF). This now appears to be making it a likely treatment for wet AMD.
In the December 2007 issue of the journal of the Federation of American Societies for Experimental Biology (FASEB), researchers described how giving endostatin to mice significantly reduces or eliminates abnormal blood vessel growth within the eye.
As reported by Alexander Marneros et al, mice without normally-occuring endostatin were about three times more likely to develop advanced AMD than normal mice. When endostatin was administered to both sets of mice, those lacking endostatin showed a reduction in the number of abnormal blood vessels. In control mice with normal levels of endostatin, the number of abnormal blood vessels was practically undetectable.
Endostatin can now be added to the growing list of antiangiogenic drugs being studied as potentially effective treatments for wet AMD.
Stem Cells From Human Skin
Two research groups have described a method of creating induced pluripoint stem cells by inserting master regulator genes into the chromosomes of human skin cells. The altered cells appear to behave like embryonic stem cells, in that they might be capable of changing into any one of the 220 types of cells in the human body. This could eventually eliminate the need for using human embryos for research. The results were to be published in Cell by Shinya Yamanaka (Kyoto University and the Gladstone Institute of Cardiovascular Disease in San Francisco), and in Science by James A. Thomson et al (University of Wisconsin).
Four genes were used to reprogram the human skin cells, all of which act to turn other genes on or off, essentially reprogramming the cells into which they are introduced. A current drawback, however, is that one of the genes has a 20 percent risk of causing cancer. This means that, until the problem is solved, the stem cells created would not be suitable for replacement in people with degenerative cell diseases such as diabetes and macular degeneration. More study is needed, also, to determine if the reprogrammed cells are indeed the same as those from embryos. If that can be confirmed, destruction of embryos and donation of human eggs would no longer be necessary for ongoing stem cell research.
Stem Cell Success in Rabbits
In December 2007, Prof. Luis E. Abad, Head of Vitreoretinal Unit of COAT-vision, and Director of CERI, Murcia, Spain, announced the outcome of a study performed to demonstrate the changes resulting from implanting stem cells into eyes of rabbits with chorioretinal tissue injury induced by laser diode (Highlights of Ophthalmology, December 2007). A recovery of 90% of the injury was reported at the healing stage, as the transplanted cells survived and migrated toward the damaged areas of the retina and transformed into the rabbit’s own epithelial cells.
JANUARY 2008
Genentech and Physicians Reach Compromise on Avastin Distribution
In collaboration with the American Academy of Ophthalmology (AAO) and the American Society of Retina Specialists (ASRS), Genentech has provided an update on its efforts to address physician questions about access to Avastin after January 1, 2008. This is another positive outcome of Genentech’s talks with the AAO and ASRS to understand physicians’ concerns about the recent change in the delivery method of Avastin.
A compromise has been reached wherein physicians can now prescribe Avastin and purchase it directly from authorized wholesale distributors who can then ship to the destination of the physician’s choice. This includes hospital pharmacies, compounding pharmacies or the physician’s office. This process is one that the AAO and ASRS believe addresses the needs of their members.
Genentech continues to believe Lucentis is the most appropriate treatment for patients with wet AMD, because it was specifically designed, formally studied, approved by the FDA and manufactured specifically for treatment of the disease. Still, Genentech believes that physicians should be able to prescribe the treatment they believe is most appropriate for their patients.
The full update is posted on the Genentech website at www.gene.com/gene/features/avastin/press-statement.html.
VA Expands Low Vision Rehabilitation Training for Vets
More than 1 million visually impaired U.S. veterans over the age of 45 will soon have access to low vision rehabilitation training through a new program of the Veterans Administration.
In a press release issued December 9, Secretary of Veterans Affairs Jim Nicholson announced that the VA will make approximately $40 million available during the next three years to establish a comprehensive nationwide rehabilitation system for veterans and active duty personnel with visual impairments. The system will enhance inpatient services and expand outpatient services throughout the 1,400 locations where VA provides health care.
Under the reorganization plan, each of VA’s 21 regional networks (called Veterans Integrated Service Networks, or VISNs) will implement a plan to provide eye care to veterans with visual impairments ranging from 20/70 to total blindness. Basic low-vision services will be available at all VA eye clinics, and every network will offer intermediate and advanced low-vision services, including a full spectrum of optical devices and electronic visual aids.
This improvement in care for visually impaired veterans is a big step forward. It is in line with the objectives of the optimum low vision rehabilitation delivery model approved in the fall by executive boards of all four professional eye care and rehabilitation academies. Read more about the model and how low vision rehabilitation can help visually impaired people maximize their vision and maintain their quality of life.
FEBRUARY 2008
Cell Phone Text Reader
Here is a brand new idea for a portable text reader. It uses a cell phone to scan printed material and then read it aloud to you. The KNFB Reader software, expected to ship around February 15, will run on a Nokia N-82 phone. The reader is very small (4 ounces and a few inches long), and it is combined with features like an MP3 player, high-speed data connection and a GPS navigation system. The software will cost $1500, and the phone will run around $550. A press release on the topic may be found on the Internet at www.npr.org/templates/story/story.php?storyId=18504117. The official web page for the reader is at www.knfbreader.com/products-mobile.php
Cleveland Scientists Develop Mouse Model of AMD
The next time you see a mouse running across the floor, take a moment to thank his cousins for their contributions to science. The most recent example of rodent heroism combined with human intellect comes from the Cole Eye Institute in Cleveland, Ohio, where researchers have created the first animal model of age-related macular degeneration (AMD).
They did this by modifying specific proteins found in mouse blood, forcing the mouse’s immune system to mount a response that led to the development of the characteristics of AMD. This historic development will help improve knowledge about the development and progression of the disease and will enable pre-clinical testing of new drugs for the dry form of AMD.
Research team leader Joe G. Hollyfield said this “presents a significant opportunity to efficiently and effectively develop and test novel therapies to both prevent the disease and slow vision
loss. Research conducted today may one day help find a cure for this progressive disease.” The research was reported in the January 27, 2008 online edition of Nature Medicine.
Phase 3 Study Enrolling Patients
Regeneron Pharmaceuticals has announced that a phase 3 study, VIEW 1, is currently enrolling patients. The VIEW 1 study is comparing the VEGF Trap-Eye and Lucentis, an antiangiogenic agent approved for use in wet AMD. The VEGF Trap is a unique fusion protein that binds all forms of vascular endothelial growth factor-a (called VEGF-A) and placental growth factor (called PLGF). Both VEGF-A and PLGF are proteins that are involved in the abnormal growth of new blood vessels.
Patients interested in enrolling in the VIEW 1 trials should contact their physicians. Continuous updates about VEGF Trap-Eye and all other antiangiogenic drugs may be found in the MD Support Library at www.mdsupport.org/library/anti-angio.html.
MARCH 2008
New Anti-PDGF Aptamer Now in Trials
Ophthotech has begun the first phase of a clinical trial of E10030, an anti-platelet derived growth factor aptamer being developed for treating wet AMD. The trial will evaluate the safety and tolerability of E10030 in combination with an antiangiogenic drug. The hope is that the combination will result in regression of new unwanted blood vessels that have begun leaking into the retina due to neovascularization.
According to Samir Patel, M.D., president and CEO of Ophthotech, E10030 is the first of three compounds, including ARC1905 and volociximab (M200), that Ophthotech is developing to treat AMD.
CD36 Deficiency May Cause Dry AMD
CD36 is a protein molecule (called an “integral membrane protein”) permanently attached to the surface of certain human cells. It plays a role in the inflammation process, but researchers have now discovered that a deficiency of the protein may cause the dry form of macular degeneration.
Researchers reported that deficiency of CD36 in rodent models led to significant progressive age-related photoreceptor degeneration. They think this is caused by a resulting down-regulation of COX2, an enzyme that is important to blood vessel formation. Uncontrolled blood vessel growth (neovascularization) is a hazard to the retina, as in wet AMD. A decrease, however, in the normal size and number of choroidal vessels will starve the photoreceptor cells, causing the dry form of the disease.
This discovery may lead to a treatment for CD36 deficiency, which could have important implications for the development of new therapies for dry AMD. The research was published on February 19, 2008 in PLoS Medicine (“CD36 Deficiency Leads to Choroidal Involution via COX2 Down-Regulation in Rodents,” Florian Sennlaub, et al, INSERM, Universite Pierre et Marie Curie, Paris).
CATT Research Beginning
On February 22, 2008 the National Eye Institute (NEI) of the National Institutes of Health (NIH) announced the start of a multicenter clinical trial (“Comparisons of Age-Related Macular Degeneration Treatments Trials”) to study the relative safety and effectiveness of Lucentis (ranibizumab) and Avastin (bevacizumab). Both anti-angiogenic drugs are being used for treatment of wet AMD.
According to Paul A. Sieving, M.D., Ph.D., director of NEI, the 2-year CATT study “will evaluate whether the treatment burden for patients can be reduced without compromising effectiveness.”
The trial will involve 1,200 patients, who will be treated with injections of either Lucentis or Avastin on a fixed schedule of once every four weeks for one year. In the second year, the patient will be assigned randomly to either an injection of the same drug every
four weeks or on a variable schedule depending upon response to treatment.
The primary outcome measure will be change in visual acuity. Secondary outcome measures will include number of treatments, anatomical changes in the retina, adverse events, and cost.
The trial will be conducted at 47 clinical centers across the country. For a list of centers, eligibility recruitments, and other information, see www.nei.nih.gov/CATT.
SAILOR Study Results Favorable
The final results from Cohort 1 of the Phase IIIb SAILOR study of Lucentis in patients with wet AMD were presented on February 23, 2008 at the Bascom Palmer Eye Institute’s Angiogenesis meeting by Dr. David Boyer (Retina-Vitreous Associates Medical Group, Los Angeles). The final, one-year data support the long-term safety and efficacy profile of Lucentis.
The study was designed to evaluate the safety of two different doses of Lucentis (0.5 mg, the FDA-approved dose, and 0.3 mg) administered once a month for three months and thereafter as needed based on re-treatment criteria. The top line results were:
Rates of ocular and non-ocular serious adverse events at one year were similar in patients receiving either 0.3 mg or 0.5 mg of Lucentis and consistent with previous studies, supporting the long-term safety of Lucentis
Rates of ocular and non-ocular adverse events at one year were generally low in both dose groups and consistent with previous studies.
One-year results also demonstrated that the FDA-approved dose of Lucentis (0.5 mg) was not associated with the higher rate of stroke observed during the planned interim analysis at six months. The data suggested a trend towards a higher incidence of stroke in the 0.5 mg dose group (1.2% vs. 0.7% in the 0.3 mg group), though the results were not statistically significant.
At one-year, patients with a prior history of stroke had a higher rate of stroke in the 0.5 group (9.6%) compared to the 0.3 group (2.7%). However, this trend was inconclusive, as the number of events was small. These data are consistent with epidemiologic data showing that prior history of stroke predisposes patients to subsequent stroke.
One-year SAILOR efficacy data suggested that treating patients with Lucentis on an as needed basis may be less effective than monthly dosing.
Interleukin-8 Linked to Dry AMD
A report in the February 28, 2008 online British Journal of Ophthalmology revealed that at least some cases of age-related macular degeneration may stem from genetically driven production of interleukin-8. The gene variant is found more commonly in patients with age-related macular degeneration.
The -251AA genotype of the interleukin-8 promoter gene has previously been found to promote release of interleukin-8, an inflammatory cytokine. Cytokines are signaling compounds in the cells that are involved in a variety of immunological, inflammatory,and infectious diseases. This latest study has shown that the -251AA genotype is often found in people with AMD. Other inflammatory diseases, cancers, and even smoking behaviors have been linked to the gene, and it may also promote angiogenesis, as in wet AMD.
The results came from a case-control study involving 478 patients with macular degeneration and 555 people with healthy eyes. 35% of the patients and 27% of controls had the -251AA genotype. If follow-up studies confirm the findings, researchers
think it may be worthwhile to test patients for the -251AA genotype and treat them with anti-inflammatory therapies.
AMD Associated With Heart Attack and Stroke
Researchers at the University of Sydney have found that people suffering from AMD have twice the risk of dying from heart attack or stroke. 3,654 people aged 49 years old and older, were studied. Five years later, 2,335 people were re-examined, and after 10 years, 1,952 were re-examined.
When the study began, early AMD was linked with a doubling of their risk of dying from heart attack or stroke over the next 10 years. The risk increased fivefold in people with late-stage AMD, and their risk of dying from stroke increased 10 times.
A major reason for the association, according to experts, is probably increased vascular problems in aging adults caused by systemic inflammation. Recent studies have found genetic variances leading to excessive inflammation, which can cause cardiovascular disease and retinal dystrophy. At least three gene variances leading to inflammation have been found in people with AMD. These are C-reactive protein and LOC387115, plus a third gene variance causing overproduction of interleukin-8, an inflammatory cytokine also associated with cardiovascular disease.
As a result of these and similar studies, genetic screening may eventually lead to development of medications to treat the dry form of AMD.
APRIL 2008
Muller Cells May Restore Sight
Over the past several years, scientists have been taking an interest in certain cells within the patient’s own eyes as having the potential to transform into stem-like (progenitor) cells. Called Muller glial cells, they would then migrate to damaged areas of the retina and replace dead cells, restoring vision lost to diseases like macular degeneration. Researchers at the Moorfields Eye Hospital in the U.K. have been studying the possibility of growing these cells in vitro and transplanting them back into the eye. For an abstract of their paper, see www.ncbi.nlm.nih.gov/pubmed/ 17525239.
Muller cells have long been known to be responsible for protecting and cleaning the retina of debris. Until now, however, it was not known what triggers their transformation into progenitor cells. On March 18, 2008, scientists at Schepens Eye Research Institute announced discovery of the chemical in the eye that is responsible. The discovery was published in the March issue of Investigative Ophthalmology and Visual Science (IOVS).
The research team, led by Dr. Dong Feng Chen (associate scientist at Schepens Eye Research Institute and Harvard Medical School) observed that the naturally occurring chemicals glutamate and aminoadipate (a derivative of glutamate) are the triggering mechanism. By injecting either of the chemicals into the eyes of healthy rats, they watched the Muller cells develop into new photoreceptors.
The next step is to test the process in animals affected by macular degeneration and retinitis pigmentosa in order to learn if vision will improve. Aminoadipate may be the chemical of choice, since it has fewer side effects than glutamate.
Robo-4 and Slit2 May Team Up Against Wet AMD
“Robo-4” sounds like a movie by Arnold Schwarzenegger, but in this case, it is a link to another potential treatment for wet AMD.
Short for “Roundabout,” Robo-4 is a protein receptor found on the surface of blood vessel cells. When it binds with another protein called Slit2, the combination stops blood vessel growth (angiogenesis). This is a natural “braking” action on the normally beneficial process of healing. Blood vessels carry needed nutrition to unhealthy parts of the body, but their development must be kept under control.
If Robo-4 is deficient, the vascular endothelial growth factor (VEGF) that initiates angiogenesis will not be blocked. New vessels, therefore, will continue to grow unabated, often leaking and causing damage. Injecting Slit2 into Robo-4 deficient rodents has been shown to inhibit VEGF activity.
These new findings were reported in the March 16, 2008 online edition of Nature Medicine. (Lead author: Dean Y. Li, M.D., Ph.D., H. A., University of Utah, Salt Lake City UT.)
There is a difference between this therapy and anti-angiogenic drugs currently in use. Instead of blocking VEGF, injection of Slit2 activates a signal to the cells to block the VEGF themselves. This new mechanism may prove to be effective alternative treatment for wet AMD. Years of study, however, lie ahead before it can be applied in practice to humans.
MAY 2008
More Benefits of Omega-3
The benefits of omega-3 (EPA and DHA) fatty acid dietary supplements for maintaining vision are well-known, and more positive effects in related areas continue to be found. One recent discovery is that omega-3 may help with symptoms of depression, and another study links prenatal omega-3 to increased visual acuity and cognitive development in babies.
A double blind study published in the Australian and New Zealand Journal of Psychiatry compared omega-3 to fluoxetine (eg. Prozac) and a combination of the two. Sixty participants were given either 1000 mg EPA, 20 mg fluoxetine, or a combination for 8 weeks. Patients were analyzed every 2 weeks, and 48 patients who completed at least 4 weeks of the study were included in the results. Using the Hamilton Depression Rating Scale (HDRS), researchers found a decrease in baseline 50% in the fluoxetine, 56% in the EPA group and 81% in the combination group. EPA and fluoxetine combination, therefore, was concluded to be superior to either of the two alone.
Another study, published in the Journal of Pediatrics, has reported that omega-3 supplementation in the last months of pregnancy may increase cognitive and motor skills in infants. U.S.
and Canadian researchers tested 109 babies at six and 11 months of age, finding that their visual acuity and cognitive and motor development were closely linked to the level of DHA in umbilical cord blood at birth.
These findings further confirm the value of omega-3 in our diet.
CABERNET Trial May Expand to 30 Sites
On April 17, 2008, NeoVista, Inc. announced that the FDA has granted the company’s request to expand the number of sites participating in its pivotal Phase 3 trial from 10 to 30 in the United States.
The CABERNET trial is designed to investigate the effect of low dose radiation combined with Lucentis for treatment of the wet form of AMD. According to NeoVista, the benefits of radiation therapy over drug therapy alone are that the treatment is effective over a longer term, it mitigates the inflammatory and fibrotic responses, it is minimally invasive, and it can be performed in a single out-patient treatment
Gene Therapy Breakthrough
According to two studies published in the New England Journal of Medicine*, doctors have, for the first time, used gene replacement therapy to restore vision in patients with Leber’s congenital amaurosis. Leber’s syndrome is a form of retinitis pigmentosa (RP) that affects children and often leads to blindness by age 30. Leaders of the studies were Albert Maguire, M.D., of the University of Pennsylvania School of Medicine and Robin R. Ali, Ph.D., of University College London.
Both research teams injected adeno-associated viruses into the subretinal space to deliver the rpe65 gene to the cells. One eye of each patient was treated.
In the U.S. study, one patient improved from an acuity of 20/2000 to 20/710. The three British patients didn’t show acuity improvement, but did improve in other areas of visual function. More sensitive night vision was reported for patients in both studies. No serious side effects or safety concerns were reported by either group. The next step is to study the treatment in younger patients.
According to Gordon Gund, chairman and co-founder of the Foundation Fighting Blindness (sponsors of the US study), “This is great news for all people affected by retinal degenerative diseases. The breakthrough paves the way for the development of gene therapies to treat a wide variety of retinal conditions including other forms of LCA, many forms of retinitis pigmentosa, Stargardt disease, Usher syndrome, and age-related macular degeneration.”
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*Effect of Gene Therapy on Visual Function in Leber’s Congenital Amaurosis (James W.B. Bainbridge, Ph.D., et al, 10.1056/NEJMoa0802268, April 27, 2008)
Should Eye Pressure Be Checked After Lucentis Treatment?
One of our members recently asked us if her doctor should check her intraocular eye pressure (IOL) after every injection of Lucentis for wet AMD. Here is a response from one of our professional advisors, K. Bailey Freund, M.D.:
In most cases we no longer perform routine IOP checks after Lucentis or Avastin. The volume of these injections is 0.05ml, which is less than the 0.09ml (Macugen) & 0.10ml (Kenalog) injection volumes. The lower volume does not cause as much of an IOP spike. We have performed thousands of injections without IOP issues. In fact, some of the current study protocols do not require post-injection IOP checks. If a patient has an elevated IOP prior to the injection or the patient has advanced glaucoma, we may check IOP after the injection in these cases.”
From Dr. Freund’s reply, it appears that pressure checks are not considered as important now that the physicians have gained more clinical experience. Genentech, Inc., maker of Lucentis, continues to recommend the procedure in their published protocol, but it is evidently not as commonly done in practice as in the past. This is good for us to know as we continue to educate ourselves about our treatment and care.
JUNE 2008
Statins and AMD
What effect do cholesterol-lowering drugs have on the retina? A pilot study in 2006 found “that treatment with simvastatin increased blood-flow velocity in the retinal arteries and veins and decreased intraocular pressure. (Nagaoka T et al. Arch Ophthalmol 2006; 124:665-670.)
This study supports the thinking that increased blood flow is generally beneficial to the retina. Recent research, however, has shown that taking statins to lower cholesterol levels might hasten the onset of wet AMD in people who are already affected by the dry form. The abstract for this study may be read on the Web at www.tinyurl.com/5ksj6a.
Considering the proven beneficial effects of drugs like simvastatin for people with circulatory problems and high cholesterol, it would be wise to keep this information in mind, but it would not be wise to stop taking them altogether without professional consultation. Until researchers have sorted out the facts, a patient’s decision should be based upon individual circumstances and discussed with professional care providers.
More details about cholesterol research as related to AMD may be found in the MD Support Library at www.mdsupport.org/ library/cholesterol.html.
U.S. Currency Design Violates the Law
On May 20, 2008, the U.S. Court of Appeals for the District of Columbia Circuit upheld a 2006 district court ruling that could force the United States to redesign its money so visually impaired people can distinguish between values.
Judge Judith Rogers wrote that Treasury Department’s current designs violate the Rehabilitation Act’s guarantee of “meaningful access.”
The Treasury Department has been working to improve the nation’s paper currency, and is currently looking at different methods to help the blind and visually impaired.
The suit was originally filed in 2002 by the American Council of the Blind and two individuals with visual impairments, Patrick Sheehan and Otis Stephens.
Laser Rejuvenates the Retina
According to a study announced at the Euretina Congress in May 2008, a laser treatment that “cleans up” Bruch’s membrane may slow down the progression to AMD.
Bruch’s membrane is the tissue that separates the photoreceptor cells (our sight cells) from the nourishing blood vessel layer of the retina. It is through Bruch’s membrane that the nourishment passes. As we age, however, the membrane can become clogged with debris, inhibiting the process and leading to cell malnutrition.
Research at St. Thomas’s Hospital in London has resulted in development of a therapeutic approach to the problem. The Retinal Rejuvenation Therapy (2RT, Ellex) uses a special green nanosecond pulse laser for “reconditioning” Bruch’s membrane and photo-regeneration. Improvement in visual function has been noted in humans during preliminary studies. Now, under the guidance of John Marshall, Ph.D., researchers are setting up a trial to treat the yet-unaffected second eyes of patients who have already lost vision in one eye due to neovascular problems.
The ultimate goal, said Dr. Marshall, is to treat patients in their 40s to keep their eyes young and prevent age-related degenerations of the retina. The treatment is noninvasive and seems to have no adverse effects on the photoreceptors or other parts of the eye.