The Age-Related Eye Disease Study 2 (AREDS2): A Multi-Center, Randomized Trial of Lutein, Zeaxanthin, and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration (AMD) Clinical Protocol support contract designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies. In addition, it will provide for outcomes research involving eye diseases and visual disorders and some preclinical studies. The focus shall be on the design of studies and the collection, analysis, and interpretation of data emanating from these studies, as well as support, and monitoring patient safety and follow-up. Contractor shall also provide analytical and data management support, as described in the work statement, for specified clinical research data bases, cost-effectiveness and economic analyses, quality of life assessment and outcomes research. This will include, but not be limited to, the following areas: analysis of Medicare and other health care databases;evaluation of existing NEI databases such as, centralized NEI Intramural Research database, the Eye Disease Case Control Study, Early Treatment Diabetic Retinopathy Study, Framingham Eye Study, and intramural AIDS and uveitis databases. Objective of Clinical Protocol: Among the estimated 937,000 blind people in the United States, approximately 90% are age 60 and older. One of the leading causes of vision loss in this age group is age-related macular degeneration. This study will evaluate whether certain vitamins and fatty acids can help prevent or slow down the progress of age-related macular degeneration. Researchers also want to learn if nutrients have effects on the development of cataracts. Patients ages 50 to 85 who are at high risk of having advanced age-related macular degeneration may be eligible for this study. About 4,000 people will participate for 5 years. At the first clinic visit, patients will have an eye examination, have their eyes photographed, and learn about the study. They will receive a supply of placebos (sugar pills) and the standard formulation of the Age-Related Eye Disease Study supplement, which has vitamin C, vitamin E, beta-carotene, zinc oxide, and cupric oxide (copper). Patients who have smoked within the past year will not receive the standard formulation, for there is an increased risk of lung cancer for people taking beta-carotene. The second visit, 1 to 3 months later, involves an eye examination, vision check, and blood sample taken if patients agree to enter a substudy of other nutrient formulations. This study uses omega-3 long-chain polyunsaturated fatty acids (fish oils): docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Patients are placed randomly into four groups: receiving a placebo;lutein and zeaxanthin only;fatty acids only;and lutein and zeaxanthin plus fatty acids. During study visits and phone calls, patients will be asked about possible side effects. After 1 year, they will have an eye examination and photographs of the eyes, and will be asked about side effects from the pills they have been taking. There will be annual follow-ups for the study's 5 year duration. NOTE: AREDS and AREDS2 are funded through a variety of mechanisms. This support contract is involved in administrative management of the project.
