Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

Phase 2

• Conditions: Diabetic Retinopathy; Macular Edema
• Interventions: Drug: Ranibizumab; Drug: Bevacizumab

• Registration Number: NCT01487629
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2011-12
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Last Update Submitted: 2011-12-09
• Last Update Posted: 2011-12-13
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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

• Aphakia
• High-risk proliferative diabetic retinopathy
• Previous treatment for DME in the past three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab	Treatment of macular edema with intravitreal Ranibizumab
Bevacizumab	Bevacizumab	Treatment of macular edema with intravitreal Bevacizumab

Primary Outcome Measures

Name	Time	Method
Central subfield macular thickness (CSFT) change	Monthly from baseline to Week 48	Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)

Secondary Outcome Measures

Name	Time	Method
Best-corrected visual acuity change	Monthly from baseline to week 48	Best-corrected visual acuity using ETDRS charts

Trial Locations

Locations (1)

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP; 🇧🇷 Ribeirão Preto, São Paulo, Brazil