At a glance
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A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)
In Brief
A Phase 2 clinical trial evaluating Laser Photocoagulation and Bevacizumab for Diabetic Retinopathy. Completed, enrolled 121 participants across 34 sites.
Detailed Summary
This study will provide preliminary data on the dose and dose interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with Diabetic Macular Edema (DME) to aid in planning a phase 3 trial. In addition, this study will provide preliminary data on the safety of intravitreally administered Avastin in subjects with DME.
Study Details
Timeline
Interventions
Laser photocoagulation at baseline; If edema present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks