Endpoints for dry AMD
Research type
Research Study
Full title
Developing and validating endpoints for clinical trials for early and late dry AMD
IRAS ID
219392
Contact name
Marketa Cilkova
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
Age-related macular degeneration (AMD) is a leading cause of blindness with onset in middle age. About 40% of early AMD patients progress to a late stage with a severe visual loss.\nSeveral therapies for dry AMD have been tested in previous clinical trials without success. It is suspected that the poor outcome was due to inability of officially recognised tests to detect the earliest signs and subtle changes in AMD. As a result, it was not possible to reliably monitor the efficacy of a therapy and tailor any treatment to individual patients’ requirements. \nIn early dry AMD, rod photoreceptors (dim light cells) degenerate earlier than cone photoreceptors (bright light cells). Despite this, the onset and progression of dry AMD is still monitored in bright light rather than dim light conditions where early AMD patients struggle the most. There is an unmet medical need to validate functional clinical tests that measure rod and cone detection thresholds under dark and light adapted conditions respectively, and patient performance in common visual tasks under dim light conditions.\nSimilarly conventional visual acuity charts are not able to monitor subtle decline in visual acuity in AMD. To tackle this issue Prof Anderson’s team have designed the Moorfields Acuity Chart (MAC) that seem to display significantly lower test-retest variability and a stronger ’signal’ for AMD. This special chart will be used under both bright and dim light conditions to assess its ability to repeatably detect more subtle visual acuity changes than is currently possible with other charts.\nWe also wish to use a patient-friendly scanning laser ophthalmoscopy method to analyse localised retinal cone mosaic to provide parallel structural measures of photoreceptor density. This will help us to determine what is the structure-function relationship between early photoreceptor changes and patients’ symptoms.
REC name
London - Bromley Research Ethics Committee
REC reference
18/LO/0193
Date of REC Opinion
5 Apr 2018
REC opinion
Further Information Favourable Opinion