NCT01487629
Unknown
Phase 2
Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Diabetic Retinopathy
- Sponsor
- University of Sao Paulo
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Central subfield macular thickness (CSFT) change
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.
Investigators
Rodrigo Jorge
Principal investigator
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion;
- •Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
- •Central subfield macular thickness greater than 300 µm
Exclusion Criteria
- •High-risk proliferative diabetic retinopathy
- •Previous treatment for DME in the past three months
Arms & Interventions
Bevacizumab
Treatment of macular edema with intravitreal Bevacizumab
Intervention: Bevacizumab
Ranibizumab
Treatment of macular edema with intravitreal Ranibizumab
Intervention: Ranibizumab
Outcomes
Primary Outcomes
Central subfield macular thickness (CSFT) change
Time Frame: Monthly from baseline to Week 48
Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)
Secondary Outcomes
- Best-corrected visual acuity change(Monthly from baseline to week 48)
Study Sites (1)
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