DARC as Macular Atrophy Biomarker: DAB
Research type
Research Study
Full title
DARC in patients with naïve wet Age-related macular degeneration as a Biomarker for macular atrophy development in patients undergoing anti-VEGF treatment (DAB)
IRAS ID
1004250
Contact name
Saad Younis
Contact email
Sponsor organisation
Imperial College NHS Trust
Eudract number
2021-005248-31
ISRCTN Number
ISRCTN22122298
Research summary
Wet macular degeneration remains the leading cause of sight loss in the developed world with numbers set to rise in line with aging population. Injections into the eye are the mainstay of treatment for wet macular degeneration in UK however; there has been increasing concern that long-term treatment with agents in the injection may lead to thinning of macula (Macular Atrophy) and is associated with irreversible vision loss. Studies suggest that this occurs in up to a third of wet AMD patients receiving eye injection treatments within the initial 24 months.
The DAB study aims to investigate if we can predict the onset of macular thinning in patients undergoing eye injections using eye scans taken at baseline, 3 months, 6 months and 12 months from onset of treatment.
40 patients with newly diagnosed wet AMD will be recruited from the Western Eye and Central Middlesex Hospital’s medical retina clinics. Eligible patients will have no evidence of Macular thinning at baseline and listed for standard of care of eye injection treatments, comprising 3 monthly injections (loading phase), followed with a combination of monitoring and treatment visits, the frequency of which will depend on patient response. On average, patients are expected to attend 7 clinic visits including the loading phase over a 12 month period. In order to avoid extra visits to the hospital site, study visits will be coordinated such that they fall on the same day as the regular care visits.
REC name
London - South East Research Ethics Committee
REC reference
22/LO/0348
Date of REC Opinion
12 Sep 2022
REC opinion
Further Information Favourable Opinion