| Trial Acronym | DAME |
| Trial Title | Treatment of severe Diabetic macular oedema with Anti-vascular endothelial growth factor (anti-VEGF) monotherapy versus treatment with Anti-VEGF followed by subthreshold Micropulse lasEr when the thickness of the central retina goes below 400 microns: a pragmatic randomised equivalence trial (DAME). |
| Clinical Area | Ophthalmology |
| Trial Status | Set Up |
| Trial Registration |
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Recruitment
Recruitment Target 264 Date Open to Recruitment Recruitment Date Closed to Recruitment -
Trial Design
Trial Design Pragmatic, allocation-concealed, single-masked (outcome assessors), multicentre, randomised (1:1), equivalence trial with an internal pilot to assess feasibility of recruitment. Study Aim To conduct a pragmatic randomised equivalence trial to assess clinical- and cost-effectiveness, safety, participant experience and acceptability of Subthreshold Micropulse Laser (SML) applied after the Central Retinal Subfield Thickness (CRT) is <400μm following initial anti-VEGF injections, compared to continued anti-VEGF monotherapy, in people who originally presented with severe DMO (CRT ≥400μm). DAME incudes a nested process evaluation to assess post-trial implementation and scalability Study Objectives:
In people initially presenting with severe DMO (CRT ≥400μm) who receive treatment with anti-VEGFs and once their macular CRT, as determined on OCT scans, has decreased to <400μm;
- To determine if the clinical effectiveness of anti-VEGFs and SML is equivalent to anti-VEGF monotherapy.
- To determine the cost-effectiveness of anti-VEGFs and SML compared to anti-VEGF monotherapy via an economic evaluation.
- To evaluate the participant experience and acceptability of anti-VEGFs and SML compared to anti-VEGF monotherapy via a mixed methods evaluation.
- To evaluate the post-trial implementation and scalability of anti-VEGFs and SML via a process evaluation.
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Chief Investigator
Chief Investigator Professor Noemi Lois, Queen’s University Belfast Email n.lois@qub.ac.uk -
Sponsor & Funder
Sponsor Belfast Health & Social Care Trust Funder National Institute for Health and Care research Health Technology Assessment Programme; NIHR157427