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Clinical Trials/NCT01487629
NCT01487629
Unknown
Phase 2

Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema

University of Sao Paulo1 site in 1 country53 target enrollmentApril 2010

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
September 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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