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

Launched by BELFAST HEALTH AND SOCIAL CARE TRUST · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying different treatment approaches for people with severe diabetic macular oedema (DMO), a condition that can cause vision loss due to fluid buildup in the eye. The trial will compare two methods: one group will receive monthly eye injections of a medication called anti-VEGF alone, while another group will start with the anti-VEGF injections and then switch to a gentle laser treatment called subthreshold micropulse laser (SML) once the thickness of the macula (the central part of the retina) drops below a certain level. The goal is to see if adding the SML treatment after the initial anti-VEGF injections can help improve outcomes for patients.

To participate in the trial, individuals must be over 18 years old and have type 1 or type 2 diabetes with severe DMO. They should also be within the first year of starting anti-VEGF treatment and still have DMO that meets specific thickness criteria. Participants will be randomly assigned to one of the two treatment groups and will attend regular study visits to monitor their progress. This study is important because it aims to find a better way to manage severe DMO, potentially improving vision and quality of life for those affected.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults (\>18 years)
• • Diabetes type 1 or type 2
• • Presented with severe centre-involving (CI)-DMO (CRT ≥400 μm)
• • Within the first year of initiating anti-VEGF therapy but who still have DMO and their CRT is below 400 μm (and it remains, at the time of randomisation) following anti-VEGF therapy in either one eye or both eyes
• Exclusion Criteria:
• • Causes of macular oedema other than DMO
• • DMO with CRT ≥400 μm
• • Receipt of anti-VEGFs before their presentation with severe DMO (previous macular laser treatment for DMO is allowed)
• • Use of unlicensed anti-VEGFs (e.g. bevacizumab)
• • Inability, for any reason, to attend study visits
• • Active proliferative diabetic retinopathy (PDR) (treated and inactive PDR is allowed)
• • Use of pioglitazone which cannot be stopped for the duration of the trial
• • Cataract surgery or laser pan-retinal photocoagulation (PRP) within the previous 6 weeks
• • Currently enrolled in a Clinical Trial of an Investigational Medical Product
• • Declined consent for participation