Research Title: Age-Related Eye Disease Study 2 (AREDS2)

Sponsor: National Eye Institute (NEI)

Principal Investigator: Jay Stallman, M.D.

Description: AREDS2 is a multi-center randomized trial of approximately 4,200 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) for the treatment of AMD and cataract. AREDS2 was designed to evaluate the effects of high supplemental doses of lutein and zeaxanthin and omega-3 LCPUFAs on the development of advanced AMD. The study enrolled participants aged 50 to 85 years, with sufficiently clear ocular media to allow accurate assessment of AMD from fundus photographs. Subjects were enrolled on the basis of the AREDS Simplified Severity Scale for defining risk categories for development of advanced age-related macular degeneration. All participants are 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 are followed for a minimum of five years.

Start Date: June 2006

Recruitment: Completed

Project Personnel: Leslie Marcus, CCRC

Location(s): Tucker; 1462 Montreal Road West, Suite 412, Tucker, GA 30084