Age-Related Eye Disease Study (AREDS) II

Participants: 50 to 85 years at risk for progression to advanced AMD

• Definition:bilateral large drusen or large drusen in 1 eye and advanced AMD in the fellow eye
• n=1940 eyes (1608 participants)

Intervention:

Original AREDS I formulation and:

Group 1: Lutein (10mg) + Zeaxanthin (2mg)
Group 2: DHA (350mg) + EPA (650mg)
Group 3: Lutein + Zeaxanthin + DHA + EPA
Group 4: Placebo

Exploratory analyses of direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.82 for development of late AMD, 0.78 for development of neovascular AMD, and 0.94 for development of central geographic atrophy.

Participants: 50 to 85 years at risk for progression to advanced AMD

• Definition:bilateral large drusen or large drusen in 1 eye and advanced AMD in the fellow eye
• n=1940 eyes (1608 participants)

Intervention:

Original AREDS I formulation and:

Group 1: Lutein (10mg) + Zeaxanthin (2mg)
Group 2: DHA (350mg) + EPA (650mg)
Group 3: Lutein + Zeaxanthin + DHA + EPA
Group 4: Placebo

There was no significant reduction in progression to advanced AMD for all 3 groups

There was no apparent effect of beta carotene elimination or lower-dose zinc on progression to advanced AMD.

More lung cancers were noted in the beta carotene vs no beta carotene group, mostly in former smokers.