Age-Related Eye Disease Study 2 (AREDS2)

Summary

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.

Conditions

• Age-related Macular Degeneration
• Cataract

Interventions

DIETARY_SUPPLEMENT

Lutein/zeaxanthin

10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules)

DIETARY_SUPPLEMENT

DHA/EPA

Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)

DRUG

Lutein/zeaxanthin and DHA/EPA

10 mg lutein and 2 mg zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Office of Dietary Supplements (ODS)

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• National Eye Institute (NEI)

  lead NIH

Principal Investigators

• Emily Y Chew, MD · National Eye Institute, National Institutes of Health

• John Paul SanGiovanni, Sc.D. · National Eye Institute, National Institutes of Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2012-10-31

Completion

2012-10-31

Countries

• United States

Study Locations