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Anti‑VEGF alone versus anti‑VEGF plus subthreshold micropulse laser for severe diabetic macular oedema after the central retina falls below 400 µm

Treatment of Severe Diabetic Macular Oedema With Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser When the Thickness of the Central Retina Goes Below 400 Microns: Pragmatic Randomised Equivalence Trial

PHASE3 · Belfast Health and Social Care Trust · NCT06985706

This will try adding subthreshold micropulse laser after initial anti‑VEGF injections to see if it helps people with severe diabetic macular oedema whose central retinal thickness drops below 400 µm.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment264 (estimated)
Ages18 Years and up
SexAll
SponsorBelfast Health and Social Care Trust (other)
Drugs / interventionsbevacizumab, ranibizumab, Brolucizumab, faricimab
Locations22 sites (Belfast and 21 other locations)
Trial IDNCT06985706 on ClinicalTrials.gov

What this trial studies

People who present with severe centre‑involving diabetic macular oedema (DMO, central retinal thickness ≥400 µm) are usually treated with repeated anti‑VEGF eye injections; this trial targets those who, within the first year of treatment, have their central retinal thickness fall below 400 µm but still have residual fluid. Participants are randomized to continue with anti‑VEGF monotherapy or to receive subthreshold micropulse laser (SML) in addition to anti‑VEGF. The trial tracks anatomical outcomes (central retinal thickness), vision, and the need for further injections over follow‑up to see whether SML can reduce treatment burden while maintaining vision. It is a multi‑center UK trial enrolling adults with type 1 or type 2 diabetes and excluding other causes of macular oedema or active proliferative disease.

Who should consider this trial

Good fit: Adults with type 1 or type 2 diabetes who originally presented with severe centre‑involving DMO (CRT ≥400 µm), started anti‑VEGF within the past year, and now have CRT <400 µm but persistent fluid are the intended participants.

Not a fit: Patients whose macular thickness remains ≥400 µm, who have non‑diabetic causes of macular oedema, active untreated proliferative diabetic retinopathy, prior use of unlicensed anti‑VEGF, or who cannot attend study visits are unlikely to be eligible or benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could reduce the number of ongoing anti‑VEGF injections and associated costs while maintaining visual outcomes.

How similar studies have performed: Subthreshold micropulse laser has shown effectiveness comparable to conventional laser for milder DMO, but using SML after initial anti‑VEGF when CRT falls below 400 µm is a newer strategy with limited prior randomized evidence.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Belfast and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Severe Diabetic Macular Oedema, Diabetic macular oedema, anti-VEGF, Subthreshold micropulse laser

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.