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Study identifier: NCT06985706 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Severe Diabetic Macular Oedema  ·  Sponsor: Belfast Health and Social Care Trust

PhasePhase 3
Planned participants264
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The macula is the centre of the retina; it gives central sight, colour and fine detail. People with diabetes may develop diabetic macular oedema (DMO). In DMO, fluid leaks from blood vessels and builds up at the macula, causing sight loss. DMO can be mild or severe; this is determined by measuring, in microns (µm), how thick the macula is. One µm is one-thousandth of a millimetre. People presenting with mild DMO (macula less than 400 µm thick; normally it is around 250 µm but varies with sex and ethnicity) are offered macular laser treatment. Laser works well for these patients. Subthreshold micropulse laser (SML), which does not damage the macula, works as well as standard laser, which produces a burn, and is cost-effective. However, many people present with severe DMO (macula 400 µm or thicker) where the laser does not work well. The standard treatment is eye injections of anti-VEGFs. VEGF stands for vascular endothelial growth factor. VEGF is high in eyes with DMO and causes blood vessel leakage. Anti-VEGFs block VEGF. They are given monthly to begin with, then every 2-3 months for months or years until DMO clears. In many patients DMO comes back after clearing and anti-VEGFs need to be re-started most often monthly initially again. To improve the care of people with severe DMO this study will compare the current standard care (anti-VEGFs alone) with a strategy in which patients begin with an anti-VEGF but switch to SML once the macula is less than 400 µm thick. Patients …

This description comes directly from the study's public registry record.

Talk to the study team

Mary Guiney  ·  +44 28 96151447  ·  mary.guiney@nictu.hscni.net

Always discuss trial participation with your own doctor first.

Locations (22)

The Royal Hospitals BelfastBelfast, United KingdomRecruiting
Birmingham and Midland Eye CentreBirmingham, United KingdomNot Yet Recruiting
Sussex Eye HospitalBrighton, United KingdomNot Yet Recruiting
Bristol Eye HospitalBristol, United KingdomNot Yet Recruiting
Frimley Park HospitalCamberley, United KingdomRecruiting
Gloucestershire Royal HospitalGloucester, United KingdomRecruiting
Hull Royal InfirmaryHull, United KingdomNot Yet Recruiting
Hinchingbrooke HospitalHuntingdon, United KingdomNot Yet Recruiting
Royal Liverpool University HospitalLiverpool, United KingdomRecruiting
Central Middlesex HospitalLondon, United KingdomRecruiting
Chelsea and Westminster HospitalLondon, United KingdomNot Yet Recruiting
Kings College HospitalLondon, United KingdomRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06985706