Age Related Macular Degeneration Update from the 23rd Annual Meeting of the American Society of Retinal Specialists

I am writing this from the 23rd Annual Meeting of the American Society of Retinal Specialists to tell you about some terrific news in the treatment of the wet or neovascular form of AMD.

Dr. Joan Miller, on behalf of the MARINA Study Group, announced the results from a large randomized trial testing of Lucentis® made by Genentech, Inc. for the treatment of the wet form of age-related macular degeneration. In short, the visual results were spectacular and much better than for any previous treatment. At 12 months, the treated groups gained 7 letters of vision compared to a loss of 10.5 letters in the control group. This 17 letter difference between the groups represents over three lines on the visual acuity chart. Forty percent of treated patients were 20/40 at 12 months which is driving vision in most states. This is the first treatment that has resulted in visual improvement in the wet form of AMD.

The treatment involves monthly injections of Lucentis® whose generic name is ranibizumab, which sounds like something from the new Harry Potter book. The medicine is injected into the eye itself but that is not particular painful and, in this case, appears to be well worth it. A few patients developed mild inflammation in the eye but this complication seems to have been mostly solved by using a new product formula.

Dr. Jeffrey Heier, on behalf of the FOCUS Study Group, reported that Lucentis® reduced the risk of visual loss in patients who also had photodynamic therapy or Visudyne®. Those results appeared to be about the same as using Lucentis® alone. Genentech is planning more studies but there were large numbers of patients in both of these well-done studies, so the results are very believable.

It will probably take a year and a half for Lucentis® to be approved by the FDA. So what should you do now if you have wet AMD? You should have treatment with Visudyne® or Macugen®, which have also been proven to be better than no treatment for the wet form of AMD. The results of these two treatments in separate studies were not as good though as that for Lucentis®. But trial results can vary so we cannot be absolutely sure. I would try either at least one Visudyne® treatment or at least three injections of Macugen® at six week intervals. If you are still losing vision, you have the following options:
1. Keep taking the same treatment since it sometimes takes a while to be effective.
2. Try switching from one type of treatment to the other. If you were being treated with Visudyne®, maybe try Macugen® or vice versa.
3. Look on the internet for a center that is participating in one of the new trials using Lucentis®, but these have not yet started
4. Ask your eye doctor about Avastin® (bevacizumab).

Avastin® is the parent molecule for the smaller Lucentis®. Genetech originally split off the smaller Lucentis® fragment from the larger Avastin® molecule because they thought Avastin® was too big to penetrate the retina. Avastin® is approved for the treatment of metastatic colon cancer, is given intravenously, and has severe side-effects like hypertension, heart attacks, and strokes. But a tiny amount of the drug has been injected directly in the eye in five patients and was effective at controlling the new blood vessels in wet AMD. So it must get through the retina and the tiny amount inside the eye probably has a much lower risk of side-effects than the large amounts give intravenously. This is an off-label use of the drug and only five patients have had this treatment so be careful. Try the proven treatments first, but this is another potentially helpful and hopeful option.

Please remember I don’t receive any money from any of these companies to recommend their treatment. The above is what I will be telling my patients. Please write if you have any questions.    

References:
Husain D, Kim I, Gauthier D, Lane AM, Tsilimbaris MK, Ezra E, Connolly EJ, Michaud N, Gragoudas ES, O'Neill CA, Beyer JC, Miller JW.  Safety and efficacy of intravitreal injection of ranibizumab in combination with verteporfin PDT on experimental choroidal neovascularization in the monkey. Arch Ophthalmol. 2005 Apr;123(4):509-16.

Michels S, Rosenfeld PJ, Puliafito CA, Marcus EN, Venkatraman AS. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration twelve-week results of an uncontrolled open-label clinical study. Ophthalmology. 2005 Jun;112(6):1035-47.

Comparison of vitamin/mineral supplements.

We recommended last time that Anna, our patient with AMD, take the vitamin and mineral supplements that were used in the Age-Related Eye Disease Study (AREDS). Patients in the AREDS took a total of: vitamin C 500mg; vitamin E 400 international units; beta-carotene 15mg (which is about 25,000 international units); zinc as zinc oxide 80 milligrams; and copper 2 milligrams every day. We know that the progression of AMD was reduced with these doses.
So we tell our patients to take those supplements and they traipse off to their local store. We checked out what was available on the internet and at our local Wal-Mart. The following products, (with their monthly cost in parenthesis) have close to the doses used in the AREDS: Visivite® ($13.95 on the internet); Viteyes® ($26.63 on the internet); Ocuvite Preservision Gel Tabs® ($13.98 at Wal-Mart); ICAPS® ($14.60 at Wal-Mart).

Now for something that is cheap but is not worth it. Wal-Mart markets Equate Vision Formula® which costs only $4.97 for 120 tabs. The bottle says to take one or two pills daily. Even if you take two pills a day you would only get 2000 IU of beta-carotene or 8% of the dose used in AREDS and 30% of the dose of Vitamin E. You would have to take 25 Equate® pills to get the AREDS dose of beta-carotene and then would give you high and probably toxic doses of vitamin C, zinc, and vitamin E. Conclusion? Don’t use Equate Vision Formula®. I hope I don’t find a horse head in my bed.

There are supplements advertised by Paul Harvey. He has various products that contain close to the AREDS doses along with a lot of other supplements of dubious value like bilberry, selenium, and chromium. They cost $44.95 for a 25 day supply. We will discuss in an upcoming blog the evidence, or lack thereof, for bilberry and selenium.

Some patients have heard about lutein which is one of the pigments in the macula and will be a subject in the next blog. There is ICAPS® with lutein but the beta-carotene dose is a measly 6,600 IU. Apparently the chemists thought the lutein would make up for the beta-carotene but there is no evidence for this. Even worse perhaps the Preservision® with lutein contains no beta-carotene at all. I would avoid these products.

Please also be aware of vitamins that state they contain 100% of the minimum daily requirements which are: vitamin C 60mg, beta-carotene 5000 IU; vitamin E 30 IU; and zinc 15mg. These doses are far below that used in AREDS. Patients with AMD may need far more than the 100% daily requirements.

I am not paid by any of these companies. I would recommend Alcon’s ICAPS® (the one without lutein) or Bausch and Lomb’s Preservision Gel Tabs® also without lutein. Both of these companies are reputable and their cost is equal to the others. Patients especially like the Preservision Gel Tabs®. They are easy to swallow and the patients need to only take two of them a day. If you want to take lutein, I would take 2-4 mg of it daily in a separate pill. Or eat a lot of highly colored fruits and vegetables.

Please come back because we have just scratched the surface.

Q&A: Should mom with significant vision loss from macular degeneration take the AREDS supplements?

Q&A: Taking part in clinical trials/choosing the correct supplement.