Anti‑VEGF alone versus anti‑VEGF plus subthreshold micropulse laser for severe diabetic macular oedema after the central retina falls below 400 µm
Official title: 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
Run by Belfast Health and Social Care Trust · NCT06985706 · Data updated 2026-11-12
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 264 (estimated) |
| Sponsor | Belfast Health and Social Care Trust Academic / other |
| Drugs / interventions | bevacizumab, ranibizumab, Brolucizumab, faricimab |
| Locations | 22 sites (Bedford and 21 other locations) |
| Status | Recruiting |
| Started | May 19, 2025 |
| Main results expected | November 30, 2028 |
| Study ends | November 30, 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT06985706 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Bedford Hospital
Bedford, United Kingdom Recruiting -
The Royal Hospitals Belfast
Belfast, United Kingdom Recruiting -
Birmingham and Midland Eye Centre
Birmingham, United Kingdom Recruiting -
Sussex Eye Hospital
Brighton, United Kingdom Recruiting -
Bristol Eye Hospital
Bristol, United Kingdom Recruiting -
Frimley Park Hospital
Camberley, United Kingdom Recruiting
Show 16 more locations
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Gloucestershire Royal Hospital
Gloucester, United Kingdom Recruiting -
Hull Royal Infirmary
Hull, United Kingdom Recruiting -
Royal Liverpool University Hospital
Liverpool, United Kingdom Recruiting -
Central Middlesex Hospital
London, United Kingdom Recruiting -
Chelsea and Westminster Hospital
London, United Kingdom Recruiting -
Kings College Hospital
London, United Kingdom Recruiting -
Moorfields Eye Hospital
London, United Kingdom Recruiting -
James Cook Hospital
Middlesbrough, United Kingdom Recruiting -
Royal Gwent Hospital
Newport, United Kingdom Recruiting -
University Hospital Southampton
Southampton, United Kingdom Recruiting -
Sunderland Eye Hospital
Sunderland, United Kingdom Recruiting -
Singleton Hospital
Swansea, United Kingdom Recruiting -
Torbay Hospital
Torquay, United Kingdom Recruiting -
Hillingdon Hospital
Uxbridge, United Kingdom Recruiting -
University Hospital of Wales
Cardiff, United Kingdom Not yet recruiting -
Queen's Medical Centre
Nottingham, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Noemi Lois — Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, United Kingdom, BT9 7BL
- Study coordinator: Mary Guiney
- Email: mary.guiney@nictu.hscni.net
- Phone: +44 28 96151447
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.