Robman, L and Guymer, R and Woods, R and Ward, S and Wolfe, R and Phung, J and Hodgson, L and Makeyeva, G and Aung, KZ and Gilbert, T and Lockery, J and Le-Pham, Y-A and Orchard, S and Storey, E and Abhayaratna, W and Reid, D and Ernst, ME and Nelson, M and Reid, C and McNeil, J, on behalf of the ASPREE Investigator Group, Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD study, Contemporary Clinical Trials Communications, 6 pp. 105-114. ISSN 2451-8654 (2017) [Refereed Article]
© 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/
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.
|Item Type:||Refereed Article|
|Keywords:||Age-related macular degeneration, AMD, aspirin, incidence, progression, randomized controlled trial|
|Research Division:||Medical and Health Sciences|
|Research Group:||Cardiorespiratory Medicine and Haematology|
|Research Field:||Cardiology (incl. Cardiovascular Diseases)|
|Objective Group:||Clinical Health (Organs, Diseases and Abnormal Conditions)|
|Objective Field:||Cardiovascular System and Diseases|
|Author:||Nelson, M (Professor Mark Nelson)|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||12 View Download Statistics|
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