ASCEND-Eye: Rationale, design and baseline characteristics for a sub-study of the ASCEND randomised trial, exploring the effects of aspirin and omega-3 fatty acids on diabetic retinopathy and age-related macular degeneration

Contemporary Clinical Trials Communications · 8 authors, 2 centres

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TL;DR

ASCEND-Eye is a pre-specified sub-study of the ASCEND randomized controlled trial.

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ASCEND-Eye is a pre-specified sub-study of the ASCEND randomized controlled trial. It uses a factorial design to test daily 100 mg aspirin versus placebo and daily 1g omega-3 fatty acids versus placebo in 15,480 adults with diabetes.

STUDY TYPE

RCT

SPECIALTY

ophthalmology

SUMMARISED BY

AI pipeline

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ORIGINAL PAPER

PMC10517364

ASCEND-Eye: Rationale, design and baseline characteristics for a sub-study of the ASCEND randomised trial, exploring the effects of aspirin and omega-3 fatty acids on diabetic retinopathy and age-related macular degeneration

Contemporary Clinical Trials Communications

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ABSTRACT

Abstract Background 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 S tudy of C ardiovascular E vents i N D iabetes) 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. Methods 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. Results 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. Discussion 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. Study registration Eudract No. 2004-000991-15; Multicentre Research Ethics Committee Ref No. 03/8/087; ClinicalTrials.gov No. NCT00135226 ; ISRCTN No. ISRCTN60635500. Keywords: Diabetic retinopathy, Age-related macular degeneration, Aspirin, Omega-3 fatty acids, Randomized trial

CITATION EXPORT

Emily Sammons, Louise Bowman, William Stevens et al.. ASCEND-Eye: Rationale, design and baseline characteristics for a sub-study of the ASCEND randomised trial, exploring the effects of aspirin and omega-3 fatty acids on diabetic retinopathy and age-related macular degeneration. Contemporary Clinical Trials Communications. (2023). https://doi.org/10.1016/j.conctc.2023.101184

AUTHORS

8 · 2 CENTRES

Emily Sammons, Louise Bowman, William Stevens, Georgina Buck, Karl Wallendszus, Imen Hammami, Sarah Parish, Jane Armitage

aMedical 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
bMedical 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