University of Tasmania
Browse

Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD study

Download (146.9 kB)
journal contribution
posted on 2023-05-22, 03:04 authored by Robman, L, Guymer, R, Woods, R, Ward, S, Wolfe, R, Phung, J, Hodgson, L, Makeyeva, G, Aung, KZ, Gilbert, T, Lockery, J, Le-Pham, Y-A, Orchard, S, Storey, E, Abhayaratna, W, Reid, D, Ernst, ME, Mark NelsonMark Nelson, Reid, C, McNeil, J
Purpose: 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.

Design: 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.

Primary outcome measures: 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.

Conclusion: 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.

History

Publication title

Contemporary Clinical Trials Communications

Volume

6

Pagination

105-114

ISSN

2451-8654

Department/School

Menzies Institute for Medical Research

Publisher

Elsevier Inc.

Place of publication

United States

Rights statement

© 2017 The Authors. Published by Elsevier Inc. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) http://creativecommons.org/licenses/by-nc-nd/4.0/

Repository Status

  • Open

Socio-economic Objectives

Clinical health not elsewhere classified

Usage metrics

    University Of Tasmania

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC