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

ASPREE-AMD 小剂量阿司匹林与老年性黄斑变性 项目总结 老年性黄斑变性(AMD)对视力有毁灭性的影响， 主要是在70岁或更老的时候。其早期发病机制 涉及视网膜内的低级别炎症过程，晚期为 与视网膜出血和萎缩有关。在这个年龄段，最多的 开出的常见药物是预防心血管事件的阿司匹林。AS 阿司匹林同时具有抗炎和抗血小板的特性，它有可能 影响AMD的病程。虽然它可以减少炎症成分在 在AMD的早期阶段，它也有可能引发出血和 在疾病更严重的阶段加重病程。 这项拟议的研究旨在评估阿司匹林对 在5000多名参与者的临床试验中AMD的病程。这是一种协作性的 (莫纳什大学和澳大利亚眼科研究中心)五年跟踪研究， 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(阿司匹林减少老年人事件)。 ASPREE父母研究有一批70岁以上的人，他们有广泛的 辅助研究可以访问的研究参数。ASPREE-AMD子项研究是 基于对使用以下设备采集的彩色视网膜图像的AMD状态的评估 高分辨率非散瞳佳能视网膜相机在基线，3年， 随机化后5年。所有图像都由经验丰富的视网膜进行AMD分级 评分员。该项目涉及在多个大都市的移动设备中进行眼睛成像， 澳大利亚的地区和农村地区。此外，有关使用的信息 治疗AMD的药物将从Medicare获得。这项研究有一个 独特的随机对照设计组合，大样本量，足够长， 成本效益，广泛的社区参与，并关注以下年龄段的人群 AMD表现(70+)。这些因素确保了高度的普适性。它的可行性一直是 经过验证，基础设施发达，所有必要的设备都已到位，员工 训练有素，经验丰富。 这项研究与NIH寻求新知识以增进健康的使命是一致的， 延年益寿，预防人类疾病，减少疾病。AMD预防是一种 两个合作机构的研究重点：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)。 完成ASPREE-AMD为期5年的后续研究可能会显著提前 目前的知识，并提供关于阿司匹林作为一种 一级预防或作为AMD进展的潜在危险因素。

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.