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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The University of Hong Kong
Hong Kong, China
Difference in number of anti-VEGF required
The number of injections of anti-VEGF required at the end of the 6 months period.
Time frame: 6 months
Change in best corrected visual acuity
The change in best corrected visual acuity among subjects in different groups at the end of the 6 months period when compared to baseline.
Time frame: 6 months
Central retinal thickness
The change in central retinal thickness among subjects in different groups at the end of the 6 months period when compared to baseline.
Time frame: 6 months
Treatment related complications
This will look at treatment related complications in terms of changes in intraocular pressure post-injection
Time frame: 6 months
Treatment related complications
This will look at treatment related complications in terms of infection
Time frame: 6 months
Treatment related complications
This will look at treatment related complications in terms of retinal detachment
Time frame: 6 months
Recurrence of macular edema
Recurrence of macular edema during the 6 months period will be monitored.
Time frame: 6 months
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