New Studies Underway: AREDS 2

Hi. I was in Peru so I haven’t kept up with the blog recently. Thanks to those who e-mailed me to ask if I was okay. I’m fine, although I had a little turista in Peru. Thank heavens for antibiotics.

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There are a lot of trials planned or underway in AMD but here are the following ones that I think are most important at this time:

1. AREDS 2- the first AREDS, (Age-Related Eye Disease Study), proved that supplementation with vitamins C and E, beta-carotene, zinc, and copper, (to reduce zinc related anemia), reduced the progression to severe AMD by about 25% over five years. High doses of these supplements were used to prove whether or not they were effective. Otherwise, if the study had shown no affect, it could’ve been argued that the doses were not high enough.

Recent studies found that diets rich in these vitamins and zinc seemed to be as effective in reducing the risk as the AREDS supplements and these diets contained much lower amounts of the micronutrients in question. Studies have also shown that eating fish, which is high in omega-3 fatty acids, reduced the risk. Some studies found that diets rich in lutein/zeaxathine, which are the yellow pigments in the macula, also appeared to reduce the risk of AMD.

AREDS 2 is testing whether supplementation with omega-3 fatty acids and/or lutein and zexanthine reduces the risk and rate of progression of AMD. Patients in AREDS 2 are allowed to take the supplements, (C, E, beta-carotene, zinc, copper), that were found to be beneficial in AREDS. They will be asked however, if they would be willing to be randomized to a lower dose of zinc (20mg instead of 80mg per day) and/or to no beta-carotene.

Following are the goals of AREDS 2 from the NEI’s website: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120 (alternate URL: http://preview.tinyurl.com/2347wx)

1. To study the effects of high supplemental doses of dietary xanthophylls (lutein and zeaxanthin)and omega-3 long-chain polyunsaturated fatty acids (LCPUFAs)(DHA and EPA)on the development of advanced AMD.
2. To study the effects of these supplements on cataract and moderate vision loss.
3. To study the effects of eliminating beta-carotene from the original AREDS formulation on the development and progression of AMD.
4. To study the effects of reducing zinc in the original AREDS formulation on the development and progression of AMD.
5. To contribute data for validation of the photographic AMD scales developed from the Age-Related Eye Disease Study.

I don’t know which group will do best. I also don’t know whether the omega-3 fatty acids and lutein/zexanthine will reduce the risk of developing severe AMD or if they will have side-effects. I would encourage you to join AREDS 2 if you have large drusen without atrophy or neovascularization in at least one eye. The centers participating in the trial are listed on the website.

Tomorrow I will discuss the second study. It’s called the Denali Study and compares PDT with Lucentis to Lucentis alone for the treatment of wet AMD.

~Jim Folk, MD