Treatment of Severe Diabetic Macular Oedema With Anti-vascular Endothelial Growth Factor Monotherapy Versus Anti-VEGF Followed by Subthreshold Micropulse Laser When Central Retina Thickness Falls Below 400 Microns

What this Trial Is About

Severe diabetic macular oedema DMO affects the central part of the retina called the macula, leading to sight loss due to fluid buildup from leaking blood vessels. This condition mainly occurs in adults with type 1 or type 2 diabetes and is measured by how thick the macula becomes in microns. This trial evaluates and compares the current standard treatment of anti-vascular endothelial growth factor anti-VEGF injections alone with a new approach where patients start with anti-VEGF injections and then switch to subthreshold micropulse laser SML treatment once the macula thickness decreases below 400 microns. Participants are randomly assigned to receive either continued anti-VEGF monotherapy or a combination where anti-VEGF treatment is followed by SML applied every 2-3 months after the macula thickness drops below 400 microns. Anti-VEGFs used include ranibizumab, aflibercept, faricimab, and brolucizumab, administered monthly initially and then spaced out as needed. SML is applied according to the study guidelines once the macula thins, aiming to reduce the number of injections required. During their participation, individuals will undergo regular optical coherence tomography OCT scans to measure macular thickness and visual acuity tests up to 104 weeks after randomization. Researchers will assess vision changes, macular thickness, quality of life, safety, treatment use, and participant experience. The study also includes follow-up questionnaires and qualitative interviews to understand patient preferences and the potential for wider implementation of the laser treatment strategy.

Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser for Treating Severe Diabetic Macular Oedema When the Central Retina Goes <400 Microns