Age-Related Eye Disease Study 2 (AREDS2)

Completed · Phase 3 · Has a placebo group

Conditions studied: Age-related Macular Degeneration, Cataract

In brief

Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.

Key facts

Study ID

NCT00345176

Run by

National Eye Institute (NEI)

People needed

4203

Starts

2006-09-01

Expected to finish

2012-10-01

Last updated by the study team

2015-05-05

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women between the ages of 50 and 85 years
• Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye

You may not qualify if…

• Ocular media not clear enough to allow good fundus photography

Where it is running

• Jones Eye Institute - UAMS — Little Rock, Arkansas, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Shiley Eye Center - UCSD — La Jolla, California, United States
• Loma Linda University — Loma Linda, California, United States
• Doheny Eye Institute — Los Angeles, California, United States
• Jules Stein Eye Institute — Los Angeles, California, United States
• VA Northern California Health Care System — Martinez, California, United States
• Southern California Desert Retina Consultants, MC — Palm Springs, California, United States
• University of California, Davis — Sacramento, California, United States
• West Coast Retina Medical Group, Inc — San Francisco, California, United States
• Pacific Eye Associates — San Francisco, California, United States
• Colorado Retina Associates — Denver, Colorado, United States
• Eldorado Retina Associates, PC — Louisville, Colorado, United States
• Yale University Eye Center — New Haven, Connecticut, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Emory University Eye Center — Atlanta, Georgia, United States
• Georgia Retina, PC — Decatur, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• The University of Illinois — Chicago, Illinois, United States
• NorthShore University HealthSystems — Glenview, Illinois, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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