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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
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 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 aged over 18 years with type 1 or type 2 diabetes and severe DMO can participate. They are randomly allocated either anti-VEGFs alone or anti-VEGFs then SML when the macula is less than 400 µm thick.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
The Royal Hospitals Belfast
RECRUITING
Belfast
Birmingham and Midland Eye Centre
NOT_YET_RECRUITING
Birmingham
Sussex Eye Hospital
NOT_YET_RECRUITING
Brighton
Bristol Eye Hospital
NOT_YET_RECRUITING
Bristol
Frimley Park Hospital
RECRUITING
Camberley
Gloucestershire Royal Hospital
RECRUITING
Gloucester
Hull Royal Infirmary
NOT_YET_RECRUITING
Hull
Hinchingbrooke Hospital
NOT_YET_RECRUITING
Huntingdon
Royal Liverpool University Hospital
RECRUITING
Liverpool
Central Middlesex Hospital
RECRUITING
London
Chelsea and Westminster Hospital
NOT_YET_RECRUITING
London
Kings College Hospital
RECRUITING
London
Moorfields Eye Hospital
RECRUITING
London
James Cook Hospital
RECRUITING
Middlesbrough
Royal Gwent Hospital
NOT_YET_RECRUITING
Newport
Queen's Medical Centre
NOT_YET_RECRUITING
Nottingham
East Surrey Hospital
NOT_YET_RECRUITING
Redhill
University Hospital Southampton
NOT_YET_RECRUITING
Southampton
Sunderland Eye Hospital
RECRUITING
Sunderland
Singleton Hospital
NOT_YET_RECRUITING
Swansea
Torbay Hospital
NOT_YET_RECRUITING
Torquay
Hillingdon Hospital
RECRUITING
Uxbridge
Contact Information
Primary
Mary Guiney
mary.guiney@nictu.hscni.net
+44 28 96151447
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 264
Treatments
Active_comparator: Subthreshold Micropulse Laser (SML)
Active_comparator: Anti-VEGF Monotherapy (standard care)
Related Therapeutic Areas
Sponsors
Collaborators: Queen's University, Belfast
Leads: Belfast Health and Social Care Trust

This content was sourced from clinicaltrials.gov