Randomized controlled trial of the effect of low dose aspirin on the course of age-related macular degeneration

ASPREE-AMD 低剂量阿司匹林与老年性黄斑变性 项目摘要 视网膜相关性黄斑变性（AMD）对视力具有破坏性影响， 主要是在70岁或以上的年龄。其发病早期 涉及视网膜内的低度炎症过程，晚期阶段是 与视网膜出血和萎缩有关。在这个年龄段， 常见的处方药物是阿司匹林，用于预防心血管事件。作为 阿司匹林具有抗炎和抗血小板的特性， 影响AMD的进程。虽然它可以减少炎症成分， 在AMD的早期阶段，它也可能引起出血， 在疾病的更晚期阶段加剧疾病的进程。 这项研究的目的是评估阿司匹林对糖尿病患者的影响的风险效益比。 在超过5000名参与者的临床试验中，这是一个合作 （莫纳什大学和澳大利亚眼科研究中心）五年随访研究， 它利用了正在进行的NIH资助的随机对照研究的资源， 临床试验ASPREE（阿司匹林在减少老年人事件）。 ASPREE父母研究有一个强大的70岁以上的人群队列， 辅助研究可以访问的研究参数。ASPREE-AMD子研究是 基于对收集的彩色视网膜图像的AMD状态的评估， 高分辨率非散瞳Canon视网膜照相机“车轮上"基线，3年， 和随机化后5年。由经验丰富的视网膜检查专家对所有图像进行AMD分级。 评分员该项目涉及在多个大城市的移动的单元中的眼睛成像， 澳大利亚的农村和地区。此外，关于使用 治疗AMD的药物将从MEDICARE获得。这项研究有一个 随机对照设计的独特组合，大样本量，足够的长度， 成本效益，广泛的社区参与，以及对年龄组的关注， AMD显示（70+）。这些因素保证了高度的普遍性。其可行性已 经过验证，其基础设施得到发展，所有必要的设备都已到位，其工作人员 训练有素经验丰富 这项研究符合NIH的使命，即寻求新的知识来增进健康， 通过预防人类疾病来延长寿命和减少疾病。预防AMD是一种 研究优先在两个合作机构：莫纳什大学（系 预防医学）和澳大利亚眼科研究中心（黄斑研究 单位）。 5年随访ASPREE-AMD研究的完成可能会显著提前 目前的知识，并提供明确的信息，对阿司匹林的影响，无论是作为一个 一级预防或作为AMD进展的潜在风险因素。

ASPREE-AMD Low-dose aspirin and age-related macular degeneration PROJECT SUMMARY 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. This study is accordant with the NIH’s mission to seek new knowledge to enhance health, lengthen life, and reduce illness by prevention of human diseases. AMD prevention is a research priority at both collaborating institutions: Monash University (Department of Preventive Medicine) and the Centre for Eye Research Australia (Macular Research Unit). The completion of the 5-year follow up ASPREE-AMD study may significantly advance current knowledge and provide definitive information on the effect of aspirin either as a primary prevention or as a potential risk factor for AMD progression.