Robman Liubov, Guymer Robyn, Woods Robyn, Ward Stephanie, Wolfe Rory, Phung James, Hodgson Lauren, Makeyeva Galina, Aung Khin Zaw, Gilbert Tom, Lockery Jessica, Le-Pham Y-Anh, Orchard Suzanne, Storey Elsdon, Abhayaratna Walter, Reid Daniel, Ernst Michael E, Nelson Mark, Reid Christopher, McNeil John
Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia.
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.
Contemp Clin Trials Commun. 2017 Jun;6:105-114. doi: 10.1016/j.conctc.2017.03.005. Epub 2017 Mar 27.
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.
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.
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.
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.
尽管阿司匹林疗法在老年人中广泛用于预防心血管疾病，但其对年龄相关性黄斑变性（AMD）的发病率、进展及严重程度的影响尚不确定。本临床试验将评估低剂量阿司匹林对AMD病程的影响。
“老年人服用阿司匹林降低事件风险”（ASPREE）试验的一项子研究，ASPREE-AMD是一项为期5年的随访双盲、安慰剂对照、随机试验，研究对象为5000名70岁及以上、基线时认知功能正常且无心血管疾病的受试者，旨在探究每日服用100毫克阿司匹林对AMD病程的影响。在基线、3年及5年随访时进行非散瞳眼底照相，以确定AMD状态。
AMD的发病率及进展情况。探索性分析将确定阿司匹林是否影响晚期AMD患者视网膜出血风险，以及其他因素，如基因型、全身性疾病、炎症生物标志物等，是否影响阿司匹林对AMD的作用。
本研究结果具有重大临床及公共意义，因为有可能确定一种潜在的低成本疗法用于全球预防AMD，并确定受AMD影响的老年人使用阿司匹林的风险/获益平衡。ASPREE-AMD研究通过在一项正在进行的大规模一级预防随机临床试验中增加视网膜成像，为确定阿司匹林对AMD发病率及进展的影响提供了独特机会。
