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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

RecruitingPhase 3Ages 18 Years - anyAllBelfast Health and Social Care Trust
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Subthreshold Micropulse Laser (SML)
  • Anti-VEGF Monotherapy (standard care)
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Where

22 sites
Bedford Hospital
Bedford, United Kingdom
The Royal Hospitals Belfast
Belfast, United Kingdom
Birmingham and Midland Eye Centre
Birmingham, United Kingdom
Sussex Eye Hospital
Brighton, United Kingdom
Bristol Eye Hospital
Bristol, United Kingdom
Frimley Park Hospital
Camberley, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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