EDNA
Research type
Research Study
Full title
Early detection of neovascular age-related macular degeneration
IRAS ID
149397
Contact name
Usha Chakravarthy
Contact email
Clinicaltrials.gov Identifier
14/NI/1120, HSC REC B
Duration of Study in the UK
6 years, 2 months, 31 days
Research summary
Neovascular age-related macular degeneration (otherwise known as wet AMD) is a serious condition that affects the macula of the eye leading to severe sight loss if left untreated. The definitive diagnosis is made using a test known as fluorescein angiography (this is the reference standard)which requires the injection of a dye into the blood circulation through a suitable vein followed by photography of the macula using specialised equipment. Once the first eye develops wet AMD the second eye follows suit at a rate of around 15% per annum. Detecting the condition early can allow better preservation of eyesight with treatment. The best method to detect the first signs of wet AMD EDNA in the second eye is not known. We are proposing a multi-centre prospective cohort study to enrol persons with wet AMD in one eye who are usually followed up in hospital eye clinic for their treatment. The fellow eye will be the study eye. Eyesight is recorded and an assessment of the macula by tomography (a special type of scan) is performed at each hospital visit and both eyes are usually monitored. This patient group therefore represent a population to determine which monitoring method is best to detect the first signs of wet AMD. In addition to the tests that can only be done in an eye clinic we are proposing to include an Amsler test (to detect distortion) and systematic questioning to elicit symptoms and thus might be applicable in the home setting. If any of the tests suggest the development of wet AMD in the fellow eye the reference standard measurement (fluorescein angiography) will be triggered. This study design will help us determine the best method of monitoring patients with wet AMD in one eye and the optimum intervals at which the various tests should be performed.
REC name
HSC REC B
REC reference
14/NI/1120
Date of REC Opinion
20 Nov 2014
REC opinion
Favourable Opinion