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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
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.
Details
| Lead sponsor | National Eye Institute (NEI) |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 4203 |
| Start date | 2006-09 |
| Completion | 2012-10 |
Conditions
- Age-related Macular Degeneration
- Cataract
Interventions
- Lutein/zeaxanthin
- DHA/EPA
- Lutein/zeaxanthin and DHA/EPA
Primary outcomes
- Development of Advanced AMD in People at Moderate to High Risk for Progression. — 5 years of follow-up
Defined as central geographic atrophy or retinal features of choroidal neovascularization detected on central grading of the stereoscopic fundus photographs or a history of treatment for advanced AMD after study enrollment.
Countries
United States