Purpose: To describe the baseline participant characteristics in the ASPREE-AMD study, investigating the effect of aspirin on AMD incidence and progression. Methods: Australian participants from the ASPirin in Reducing Events in the Elderly (ASPREE) trial, randomized to 100 mg aspirin daily or placebo, had non-mydriatic, digital color fundus images graded according to the Beckman AMD classification. Associations with AMD were determined for baseline characteristics and genetic risk variants. Results: ASPREE-AMD sub-study enrolled 4993 participants with gradable macular images. Median age was 73.4 years (IQR, 71.5, 76.6), 52% were female, 10% had diabetes mellitus, 73% had hypertension, and 44% were former/current smokers. Early, intermediate and late AMD (detected in 20.6%, 16.1%, 1.1%, respectively), significantly associated with age, were also associated with increasing HDL levels: OR=1.52(95%CI,1.26, 1.84), OR=1.43(1.17, 1.77) and OR=1.96(1.02, 3.76), respectively. Female sex was associated with early [OR=1.37(1.16, 1.62)], and intermediate [OR=1.35(1.12, 1.63)] AMD, as was previous regular use of aspirin, with OR=1.46(1.11, 1.92) and OR=1.37(1.01, 1.85), respectively. Current smoking had increased odds for late AMD, OR=4.02(1.42, 11.36). Genetic risk variant rs3750846 (ARMS2/HTRA1) was associated with each AMD stage (p<0.001), risk variants rs570618 and rs10922109 (CFH) with intermediate and late AMD (p<0.001), and rare variant rs147859257 (C3) with late AMD (p<0.001). The randomized groups were well balanced for all analyzed AMD risk factors. Conclusions: Observed associations are typical of AMD. The ASPREE-AMD clinical trial provides a unique opportunity to determine the risks and benefits of low-dose aspirin for AMD incidence and progression in elderly population.
- Age-related macular degeneration
- randomized controlled trial
- baseline characteristics