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 (DAME): a pragmatic randomised equivalence trial

Research question: In patients who were treated with anti-vascular endothelial growth factor (anti-VEGF) therapy after presenting with diabetic macular oedema (DMO) with central retinal thickness (CRT) of 400µm or more, is the application of subthreshold micropulse laser (SML) after their CRT goes below 400µm equivalent to continuing with anti-VEGF monotherapy?

Background: DMO causes sight loss in people living with diabetes. Currently, severe DMO (with CRT of 400µm or more, measured using optical coherence tomography) is treated with anti-VEGFs for months or years until it clears. In many, DMO returns when anti-VEGFs are stopped requiring their re-initiation.

Anti-VEGFs are expensive, require frequent treatment/follow-up and have risks including endophthalmitis, which could cause blindness. Injections are associated with patient anxiety, and fear of injections is one of the most common reasons for discontinuation of anti-VEGFs. SML has been shown to be clinically effective and cost-effective to treat DMO with CRT