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Robman L, Guymer R, Woods R, et al. Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD study. Contemp Clin Trials Commun. 2017;6:105-114doi: 10.1016/j.conctc.2017.03.005.
Robman, L., Guymer, R., Woods, R., Ward, S., Wolfe, R., Phung, J., Hodgson, L., Makeyeva, G., Aung, K. Z., Gilbert, T., Lockery, J., Le-Pham, Y. A., Orchard, S., Storey, E., Abhayaratna, W., Reid, D., Ernst, M. E., Nelson, M., Reid, C., & McNeil, J. (2017). 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, 6105-114. https://doi.org/10.1016/j.conctc.2017.03.005
Robman, Liubov, et al. "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 vol. 6 (2017): 105-114. doi: https://doi.org/10.1016/j.conctc.2017.03.005
Robman L, Guymer R, Woods R, Ward S, Wolfe R, Phung J, Hodgson L, Makeyeva G, Aung KZ, Gilbert T, Lockery J, Le-Pham YA, Orchard S, Storey E, Abhayaratna W, Reid D, Ernst ME, Nelson M, Reid C, McNeil J. Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD study. Contemp Clin Trials Commun. 2017 Jun;6:105-114. doi: 10.1016/j.conctc.2017.03.005. Epub 2017 Mar 27. PMID: 28736754; PMCID: PMC5518696.
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Contemp Clin Trials Commun. 2017 Jun;6:105-114. doi: 10.1016/j.conctc.2017.03.005. Epub 2017 Mar 27.

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

Liubov Robman, Robyn Guymer, Robyn Woods, Stephanie Ward, Rory Wolfe, James Phung, Lauren Hodgson, Galina Makeyeva, Khin Zaw Aung, Tom Gilbert, Jessica Lockery, Y-Anh Le-Pham, Suzanne Orchard, Elsdon Storey, Walter Abhayaratna, Daniel Reid, Michael E Ernst, Mark Nelson, Christopher Reid, John McNeil

Affiliations

  1. Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia.
  2. Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.
  3. Monash Ageing Research Centre, Monash University, The Kingston Centre, Warrigal Rd, Cheltenham, VIC, 3192, Australia.
  4. College of Medicine, Biology and Environment, Australian National University, Canberra, ACT, 0200, Australia.
  5. College of Pharmacy, and Department of Family Medicine, The University of Iowa, Iowa City, IA 52242, USA.
  6. Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, 7000, Australia.
  7. School of Public Health, Curtin University, Perth, WA, 6102, Australia.

PMID: 28736754 PMCID: PMC5518696 DOI: 10.1016/j.conctc.2017.03.005

Abstract

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.

Keywords: AMD; Age-related macular degeneration; Aspirin; Incidence; Progression; Randomized controlled trial

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