Status:
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
Lead Sponsor:
Belfast Health and Social Care Trust
Collaborating Sponsors:
Queen's University, Belfast
Conditions:
Severe Diabetic Macular Oedema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 build...
Detailed Description
Background DMO is a leading cause of sight loss in people living with diabetes (PLWD). Considering the prevalence of DMO (7%) and diabetes (\~4.8 million), around 336,000 PLWD have DMO in the UK. With...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT06985706
Start Date
May 19 2025
End Date
November 30 2028
Last Update
September 19 2025
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
The Royal Hospitals Belfast
Belfast, United Kingdom
2
Birmingham and Midland Eye Centre
Birmingham, United Kingdom
3
Sussex Eye Hospital
Brighton, United Kingdom
4
Bristol Eye Hospital
Bristol, United Kingdom