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

PHASE3RecruitingINTERVENTIONAL
Enrollment

264

Participants

Timeline

Start Date

May 19, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

November 30, 2028

Conditions
Severe Diabetic Macular Oedema
Interventions
PROCEDURE

Subthreshold Micropulse Laser (SML)

SML will be applied in line with the DAME Guideline and follow the DAME participant pathway.

DRUG

Anti-VEGF Monotherapy (standard care)

Anti-VEGFs including ranibizumab and biosimilars, aflibercept, faricimab, and brolucizumab will be used, as per the standard of care at participating sites. The anti-VEGF should be administered in line with the summary of product characteristics (SmPC).

Trial Locations (22)

Unknown

RECRUITING

The Royal Hospitals Belfast, Belfast

NOT_YET_RECRUITING

Birmingham and Midland Eye Centre, Birmingham

NOT_YET_RECRUITING

Sussex Eye Hospital, Brighton

NOT_YET_RECRUITING

Bristol Eye Hospital, Bristol

RECRUITING

Frimley Park Hospital, Camberley

RECRUITING

Gloucestershire Royal Hospital, Gloucester

NOT_YET_RECRUITING

Hull Royal Infirmary, Hull

NOT_YET_RECRUITING

Hinchingbrooke Hospital, Huntingdon

RECRUITING

Royal Liverpool University Hospital, Liverpool

RECRUITING

Central Middlesex Hospital, London

NOT_YET_RECRUITING

Chelsea and Westminster Hospital, London

RECRUITING

Kings College Hospital, London

RECRUITING

Moorfields Eye Hospital, London

RECRUITING

James Cook Hospital, Middlesbrough

NOT_YET_RECRUITING

Royal Gwent Hospital, Newport

NOT_YET_RECRUITING

Queen's Medical Centre, Nottingham

NOT_YET_RECRUITING

East Surrey Hospital, Redhill

NOT_YET_RECRUITING

University Hospital Southampton, Southampton

RECRUITING

Sunderland Eye Hospital, Sunderland

NOT_YET_RECRUITING

Singleton Hospital, Swansea

NOT_YET_RECRUITING

Torbay Hospital, Torquay

RECRUITING

Hillingdon Hospital, Uxbridge

All Listed Sponsors
collaborator

Queen's University, Belfast

OTHER

lead

Belfast Health and Social Care Trust

OTHER

NCT06985706 - 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 | Biotech Hunter | Biotech Hunter