To Compare Anti-VEGF Monotherapy With Anti-VEGF and EPM Grid Laser Combination Therapy for Diabetic Macular Edema
- Sponsor
- The University of Hong Kong
- Study ID
- NCT02462304
- Phase
- PHASE4
- Status
- Unknown
Conditions
- Diabetic Macula Edema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- End-Point-Management grid laser — PROCEDURE
- ranibizumab — DRUG
- Bevacizumab — DRUG
Study Details
Objectives: To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth Factor and end-point-management grid laser photocoagulation for diabetic macular edema. Study design: Open-label non-randomized interventional study. Study overview: This study aims to look at the efficacy of treating diabetic macular edema (DME) with either anti-Vascular Endothelial Growth Factor(anti-VEGF) monotherapy, compared with combination therapy with anti-VEGF and End-Point-Management (EPM) grid laser photocoagulation, over a period of 6 months. Various sites from across Asia (Japan, South Korea, Hong Kong) will participate. Depending on the availability of EPM laser, sites can either contribute to the 'Anti-VEGF monotherapy' arm, or to the 'Combination therapy' arm.
Key Dates
- First listed
- Jun 4, 2015
- Start date
- Jun 30, 2015
- Status verified
- Apr 2016
- Primary completion
- Jun 30, 2017
- Completion
- Dec 31, 2017
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Combination Anti-VEGF and EPM laserSubjects will receive both anti-VEGF injections and EPM laser.
- Active Comparator: Anti-VEGF monotherapySubjects will receive anti-VEGF injections monotherapy.
Primary Outcome Measure
Difference in number of anti-VEGF required [ Time Frame: 6 months ]