Sammons Emily, Bowman Louise, Stevens William, Buck Georgina, Wallendszus Karl, Hammami Imen, Parish Sarah, Armitage Jane
Medical Research Council Population Health Research Unit, Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, Nuffield Department of Population Health, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.
Medical Research Council Population Health Research Unit, Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, Nuffield Department of Population Health, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.
Contemp Clin Trials Commun. 2023 Jul 5;35:101184. doi: 10.1016/j.conctc.2023.101184. eCollection 2023 Oct.
Aspirin and omega-3 fatty acids (FAs) have potential disease-modifying roles in diabetic retinopathy (DR) and age-related macular degeneration (AMD), but randomized evidence of these effects is limited. We present the rationale and baseline characteristics of ASCEND-Eye, a sub-study of the double-blind, 2x2 factorial design, randomized placebo-controlled ASCEND (A Study of Cardiovascular Events iN Diabetes) trial of 100 mg aspirin daily and, separately, 1g omega-3 FAs daily for the primary prevention of serious cardiovascular events, in 15,480 British adults, aged 40 years or older with diabetes.
Eye events will be derived from three sources: 1) participant follow-up questionnaires from ASCEND, 2) electronic NHS Diabetic Eye Screening Programme (DESP) data and 3) responses to the National Eye Institute's Visual Function Questionnaire-25 (NEI-VFQ-25) sent to a subset of participants after the main trial ended. Analytic cohorts and outcomes relevant to these data sources are described. The primary outcome is referable diabetic eye disease, a secondary outcome is incident AMD events.
Participant-reported events were ascertained for the full cohort of randomized individuals who were followed up over 7.4 years in ASCEND (n = 15,480). Linked DESP data were available for 48% of those (n = 7360), and 57% completed the NEI-VFQ-25 (n = 8839). The baseline characteristics of these three cohorts are presented.
Establishing the risks and benefits of drugs commonly taken by people with diabetes, the elderly, or both, and finding new treatments for DR and AMD is important. ASCEND-Eye provides the opportunity to evaluate the effect of aspirin and, separately, omega-3 FAs for both conditions.
Eudract No. 2004-000991-15; Multicentre Research Ethics Committee Ref No. 03/8/087; ClinicalTrials.gov No. NCT00135226; ISRCTN No. ISRCTN60635500.
阿司匹林和ω-3脂肪酸（FAs）在糖尿病视网膜病变（DR）和年龄相关性黄斑变性（AMD）中具有潜在的疾病改善作用，但这些作用的随机证据有限。我们介绍了ASCEND-Eye的基本原理和基线特征，ASCEND-Eye是一项双盲、2×2析因设计、随机安慰剂对照的ASCEND（糖尿病心血管事件研究）试验的子研究，该试验在15480名40岁及以上的英国糖尿病成年人中，每天服用100毫克阿司匹林以及每天单独服用1克ω-3脂肪酸，用于严重心血管事件的一级预防。
眼部事件将来自三个来源：1）ASCEND的参与者随访问卷；2）英国国家医疗服务体系糖尿病眼部筛查计划（DESP）的电子数据；3）在主要试验结束后发送给一部分参与者的美国国立眼科研究所视觉功能问卷-25（NEI-VFQ-25）的回复。描述了与这些数据源相关的分析队列和结局。主要结局是可转诊的糖尿病眼病，次要结局是新发AMD事件。
在ASCEND中对随机分组个体的整个队列进行了7.4年的随访，确定了参与者报告的事件（n = 15480）。其中48%（n = 7360）可获取相关的DESP数据，57%（n = 8839）完成了NEI-VFQ-25。呈现了这三个队列的基线特征。
确定糖尿病患者、老年人或两者通常服用的药物的风险和益处，以及寻找DR和AMD的新治疗方法很重要。ASCEND-Eye提供了评估阿司匹林以及ω-3脂肪酸对这两种疾病影响的机会。
欧洲药品管理局临床试验编号2004-000991-15；多中心研究伦理委员会参考编号03/8/087；美国国立医学图书馆临床试验注册中心编号NCT00135226；国际标准随机对照试验编号ISRCTN60635500。
