Age-Related Eye Disease Study 2 (AREDS2)
The Age-Related Eye Disease Study 2 (AREDS2), sponsored by the National Eye Institute (NEI), is a multicenter, randomized clinical trial of over 4,000 participants designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 LCPUFAs (DHA and EPA) for the treatment of AMD.
The objectives of AREDS2 are to:
1) Study the effects of high supplemental doses of the dietary xanthophylls (lutein and zeaxanthin) and
omega-3 LCPUFAs (DHA and EPA) on the development of advanced AMD.
2) Study the effects of these supplements on moderate vision loss (doubling of the visual angle or the
loss of 15 or more letters on the ETDRS chart).
3) Study the effects of these supplements on cataract.
4) Study the effects of eliminating beta-carotene in the original AREDS formulation on the development
and progression of AMD.
5) Study the effects of reducing zinc in the original AREDS formulation on the development and
progression of AMD.
6) Validate the fundus photographic AMD scale developed from the Age-Related Eye Disease Study.
The study objectives will be accomplished by collecting and assessing the data on over 4,000 AREDS2 men and women aged 50 to 85 years, who at the time of enrollment, have sufficiently clear lenses for quality fundus photographs and have either: 1) bilateral large drusen or 2) large drusen in one eye and advanced AMD (neovascular AMD or central geographic atrophy) in the fellow eye.
82 clinical centers across the United States.