Treatment of diabetic macular oedema
Research type
Research Study
Full title
Treatment of severe Diabetic macular oedema with Anti-vascular endothelial growth factor (anti-VEGF) monotherapy versus treatment with anti-VEGF followed by subthreshold Micropulse lasEr when the thickness of the central retina goes below 400 microns: a pragmatic randomised equivalence trial.
IRAS ID
1010626
Contact name
Noemi Lois
Contact email
Sponsor organisation
Belfast Health and Social care Trust
ISRCTN Number
ISRCTN12693443
Research summary
The macula is the centre of the retina; it gives central sight, colour and fine detail. People with diabetes may develop diabetic macular oedema (DMO). In DMO, fluid leaks from blood vessels and builds-up at the macula, causing sight loss. DMO can be mild or severe; this is determined by measuring, in microns (µm), how thick the macula is. One µm is one-thousandth of a millimetre.
People presenting with mild DMO (macula less than 400µm thick; normally it is around 250µm but varies with sex and ethnicity) are offered macular laser treatment. Laser works well for these patients. Our(NIHR) DIAMONDS showed that subthreshold micropulse laser (SML), which does not damage the macula, works as well as standard laser, which produces a burn, and is cost-effective in DIAMONDS, patients receiving SML received 2-3 treatments over two years and were followed up at 3-4 month intervals.
However, many people present with severe DMO (macula 400µm or thicker) where laser does not work well. The standard treatment is eye injections of anti-VEGFs. VEGF stands for vascular endothelial growth factor. VEGF is high in eyes with DMO and causes blood vessel leakage. Anti-VEGFs block VEGF. They are given monthly to begin with; then every 2-3 months for months or years until DMO clears. In many patients DMO comes back after clearing and anti-VEGFs need to be re-started most often monthly initially again.
To improve the care of people with severe DMO we propose the DAME trial. It will compare the current standard care (anti-VEGFs alone) with a strategy in which patients begin with an anti-VEGF but switch to SML once the macula is less than 400µm thick.REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0330
Date of REC Opinion
15 Nov 2024
REC opinion
Further Information Favourable Opinion