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Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of
Liubov Robman1,2, Robyn Guymer2, Robyn Woods1
1Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia.
Insights
This study investigates if daily low-dose aspirin affects age-related macular degeneration (AMD) progression in older adults. Findings may reveal a new, low-cost therapy for preventing AMD worldwide.
Area of Science:
- Ophthalmology
- Geriatrics
- Cardiovascular Disease Prevention
Background:
- Aspirin is widely used for cardiovascular prevention in older adults.
- The impact of aspirin on age-related macular degeneration (AMD) incidence, progression, and severity remains uncertain.
- This study addresses the need to clarify aspirin's role in AMD management.
Purpose of the Study:
- To evaluate the effect of low-dose aspirin on the course of age-related macular degeneration (AMD).
- To determine if aspirin influences AMD incidence and progression in elderly individuals.
- To explore potential low-cost therapeutic strategies for AMD prevention.
Main Methods:
- A 5-year, double-blind, placebo-controlled, randomized trial (ASPREE-AMD) involving 5000 participants aged 70+.
- Participants had normal cognitive function and no cardiovascular disease at baseline.
- Non-mydriatic fundus photography assessed AMD status at baseline, 3, and 5 years.
Main Results:
- The study is designed to determine the incidence and progression of AMD.
- Exploratory analyses will examine aspirin's effect on retinal hemorrhage risk in late AMD.
- Investigating the influence of genetic factors, systemic diseases, and biomarkers on aspirin's effect on AMD.
Conclusions:
- Findings will inform clinical practice regarding aspirin use in the elderly with or at risk for AMD.
- The study may identify a cost-effective therapy for preventing AMD globally.
- This research will clarify the risk-benefit balance of aspirin for AMD-affected older adults.
Purpose:
Although aspirin therapy is used widely in older adults for prevention of cardiovascular disease, its impact on the incidence, progression and severity of age-related macular degeneration (AMD) is uncertain. The effect of low-dose aspirin on the course of AMD will be evaluated in this clinical trial.
Design:
A sub-study of the 'ASPirin in Reducing Events in the Elderly' (ASPREE) trial, ASPREE-AMD is a 5-year follow-up double-blind, placebo-controlled, randomized trial of the effect of 100 mg daily aspirin on the course of AMD in 5000 subjects aged 70 years or older, with normal cognitive function and without cardiovascular disease at baseline. Non-mydriatic fundus photography will be performed at baseline, 3-year and 5-year follow-up to determine AMD status.
Primary Outcome Measures:
The incidence and progression of AMD. Exploratory analyses will determine whether aspirin affects the risk of retinal hemorrhage in late AMD, and whether other factors, such as genotype, systemic disease, inflammatory biomarkers, influence the effect of aspirin on AMD.
Conclusion:
The study findings will be of significant clinical and public interest due to a potential to identify a possible low cost therapy for preventing AMD worldwide and to determine risk/benefit balance of the aspirin usage by the AMD-affected elderly. The ASPREE-AMD study provides a unique opportunity to determine the effect of aspirin on AMD incidence and progression, by adding retinal imaging to an ongoing, large-scale primary prevention randomized clinical trial.
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