Purpose: 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. To study the effects of these supplements on cataract and moderate vision loss. To study the effects of eliminating beta-carotene from the original AREDS formulation on the development and progression of AMD. To study the effects of reducing zinc in the original AREDS formulation on the development and progression of AMD. To contribute data for validation of the photographic AMD scales developed from the Age-Related Eye Disease Study.Description: AREDS 2 is a multi-center randomized trial of 4,000 participants designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs (DHA and EPA) on the progression to advanced AMD. The study will enroll participants aged 50 to 85 years, with sufficiently clear ocular media to allow accurate assessment of AMD from fundus photographs. Participants should have either bilateral large drusen (>125 microns) or large drusen in one eye and advanced AMD in the fellow eye. All participants will be offered additional treatment with the original AREDS formulation (now considered standard of care) and 3 variations of this formula. These are: (1) no beta-carotene; (2) lower amounts of zinc; and (3) no beta-carotene and lower amounts of zinc. Eligible participants will be followed for a minimum of five years.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research and Development Contracts (N01)
Project #
N01EY50007-9-0-1
Application #
7648818
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
2008
Total Cost
$2,948,356
Indirect Cost
Name
Emmes Corporation
Department
Type
DUNS #
096360284
City
Rockville
State
MD
Country
United States
Zip Code
20850