COSMOS-Eye
Trial question
What is the role of cocoa extract supplementation in patients with age-related macular degeneration?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
59.0% female
41.0% male
N = 21442
21442 patients (12666 female, 8776 male).
Inclusion criteria: adult patients aged ≥ 60 years with age-related macular degeneration.
Key exclusion criteria: kidney failure or dialysis; liver cirrhosis; other serious conditions that precluded participation; extreme sensitivity to caffeine.
Interventions
N=10719 cocoa extract supplement (500 mg/day cocoa flavanols, including 80 mg epicatechin).
N=10723 placebo (matching placebo).
Primary outcome
Incidence of age-related macular degeneration plus progression to advanced age-related macular degeneration among participants with age-related macular degeneration at baseline
1.5%
1.7%
1.7 %
1.3 %
0.8 %
0.4 %
0.0 %
Cocoa extract
supplement
Placebo
No significant
difference ↔
No significant difference in incidence of age-related macular degeneration plus progression to advanced age-related macular degeneration among participants with age-related macular degeneration at baseline (1.5% vs. 1.7%; HR 0.87, 95% CI 0.71 to 1.08).
Secondary outcomes
No significant difference in incidence of visually significant age-related macular degeneration (0.59% vs. 0.64%; HR 0.9, 95% CI 0.64 to 1.27).
No significant difference in incidence of advanced age-related macular degeneration (0.24% vs. 0.35%; HR 0.7, 95% CI 0.42 to 1.15).
No significant difference in incidence of age-related macular degeneration (1.4% vs. 1.6%; HR 0.88, 95% CI 0.7 to 1.09).
Conclusion
In adult patients aged ≥ 60 years with age-related macular degeneration, cocoa extract supplement was not superior to placebo with respect to incidence of age-related macular degeneration plus progression to advanced age-related macular degeneration among participants with age-related macular degeneration at baseline.
Reference
William G Christen, Pamela M Rist, M Vinayaga Moorthy et al. Cocoa Flavanol Supplementation and Risk of Age-Related Macular Degeneration: An Ancillary Study of the COSMOS Randomized Clinical Trial. JAMA Ophthalmol. 2025 Mar 27:e250353. Online ahead of print.
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