ASPREE randomized clinical trial: Low-dose aspirin has no effect on incidence or progression of AMD

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A recent Australian study reported that low-dose aspirin does not seem to affect the incidence or progression of age-related macular degeneration (AMD),¹ according to first author Liubov D. Robman, MBBS, PhD. She is from the School of Public Health and Preventive Medicine, Monash University, and the Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, both in Melbourne, Victoria, Australia.

Identifying new treatments to prevent or slow progression of AMD is mandatory considering that it is the leading cause of irreversible loss of vision in elderly patients, Robman and colleagues emphasized.

To determine the effects of aspirin on AMD, the investigators undertook a secondary analysis of the effects of long-term, low-dose aspirin in over 3000 older adults who satisfied the inclusion criteria in the Aspirin in Reducing Events in the Elderly–AMD (ASPREE-AMD) study (ACTRN12613000755730). This study is an Australian-multicenter, randomized, double-masked, placebo-controlled clinical trial that looked at the efficacy of low-dose aspirin (100 mg daily) in prolonging disability-free survival among older individuals, they explained.

Retinal photographs were obtained at baseline from March 2010 to January 2015, and again at 3 and 5 years after patient randomization to aspirin or placebo. The patients’ AMD status was determined using color retinal images and treatment records. Australian participants in ASPREE were included in the substudy who were aged 70 years and older and had no dementia, a physical disability that affected independence, cardiovascular disease, or a chronic illness that limited their 5-year survival; they also had to have gradable retinal images at baseline.

The main outcome measure was the incidence of AMD and progression from early/intermediate to late AMD.

ASPREE-AMD data analysis

A total of 3171 patients were analyzed for AMD incidence and progression (median interquartile range [IQR] age, 73.5 years; range, 71.5-76.4; 51% women). The median (IQR) follow-up time was 3.1 (3.0-3.5) years.

The authors reported that the cumulative AMD incidence was 195 of 1,004 (19.4%) in the aspirin group and 187 of 979 (19.1%) in the placebo group (relative risk [RR], 1.02; 95% confidence interval [CI], 0.85-1.22; P = 0.86). The cumulative progression from early/intermediate AMD to late AMD occurred in 14 of 615 (2.3%) patients in the aspirin group and 18 of 573 (3.1%) in the placebo group (RR, 0.72; 95% CI, 0.36-1.44; P = 0.36).

The incidence rates of development of AMD were similar in both groups. The progression rate to late AMD was slightly lower in the aspirin group but did not differ significantly from that in the placebo group.

The investigators commented, “In this trial, low-dose aspirin administered for 3 years did not affect the incidence of AMD. The evidence was weaker for progression of AMD due to the low number of progressed cases. Overall, these results do not support the suggestion that low-dose daily aspirin prevents the development or progression of AMD.”

Reference:

1. Robman LD, Wolfe R, Woods RL, et al. Effect of low-dose aspirin on the course of age-related macular degeneration: a secondary analysis of the ASPREE randomized clinical trial. 2024; JAMA Ophthalmol. 2024; ublished online May 23. doi:10.1001/jamaophthalmol.2024.1584