Phase 3
N=4,203
Age-Related Eye Disease Study 2 (AREDS2)
Age-related Macular Degeneration · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00345176 ↗Enrolled (actual)
4,203
Serious AEs
47.3%
Results posted
Dec 2013
Primary outcome: Primary: Development of Advanced AMD in People at Moderate to High Risk for Progression. — 493; 468; 507; 472 Eyes — p=<0.013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lutein/zeaxanthin (Dietary_supplement); DHA/EPA (Dietary_supplement); Lutein/zeaxanthin and DHA/EPA (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- National Eye Institute (NEI)
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Development of Advanced AMD in People at Moderate to High Risk for Progression. |
493; 468; 507; 472 | <0.013 sig |
| SECONDARY Progression to Moderate Vision Loss |
515; 509; 519; 506 | <0.05 sig |
| SECONDARY Adverse Events |
81; 87; 96; 104; 479; 484 | <0.05 sig |
| SECONDARY Progression to Cataract Surgery |
708; 681 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women between the ages of 50 and 85 years
- Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye
Exclusion Criteria
- Ocular media not clear enough to allow good fundus photography
Data sourced from ClinicalTrials.gov (NCT00345176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.