Randomized controlled trial of the effect of low dose aspirin on the course of agerelated macular degeneration

Age–related macular degeneration (AMD) has a devastating effect on vision, predominantly at the age of 70 years or older. Its pathogenesis at the early stages involves a low-grade inflammatory process within the retina, and the late stages are associated with retinal haemorrhages and atrophy. In this age group, one of the most common medications prescribed is aspirin for prevention of cardiovascular events. As aspirin has both anti-inflammatory and antiplatelet properties, it has the potential to influence the course of AMD. Whilst it could reduce the inflammatory component at earlier stages of AMD, it is also plausible that it could provoke haemorrhaging and exacerbate the course of the disease at its more advanced stage.
The proposed study aims to evaluate risk to benefit ratios of the effect of aspirin on the course of AMD in the clinical trial on over 5000 participants. It is a collaborative (Monash University and Centre for Eye Research Australia) five-year follow up study, which capitalizes on the resources of the ongoing NIH-funded randomized controlled clinical trial ASPREE (ASPirin in Reducing Events in the Elderly).
The ASPREE parent study has a strong cohort of people over the age of 70 with extensive study parameters, which ancillary studies can access. The ASPREE-AMD sub-study is based on the assessment of the AMD status of the colour retinal images collected with high resolution non-mydriatic Canon retinal cameras ‘on wheels’ at baseline, 3 years, and 5 years after randomization. All images are graded for AMD by experienced retinal graders. This project involves eye imaging in mobile units at multiple metropolitan, regional, and rural areas of Australia. Additionally, the information on the use of medications for AMD treatment will be obtained from MEDICARE. This study has a unique combination of randomised controlled design, large sample size, sufficient length, cost-effectiveness, wide community involvement, and a focus on the age group when AMD manifests (70+). These factors assure high generalisability. Its feasibility has been proven, its infrastructure developed, all required equipment is in place and its staff are trained and experienced.
Baseline and year 3 follow up data collection has been funded by NHMRC. In the NIH application we requested funds for 5-year follow up of the ASPREE-AMD participants.
The completion of the 5-year follow up ASPREE-AMD study may significantly advance current knowledge and provide definitive information on the effect of as a primary prevention or as a potential risk factor for AMD progression.