Overview

This trial is active, not recruiting.

Conditions diabetic retinopathy, macular edema
Treatments bevacizumab, ranibizumab
Phase phase 2
Target VEGF
Sponsor University of Sao Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date April 2010
End date September 2012
Trial size 53 participants
Trial identifier NCT01487629, 13368/2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment of macular edema with intravitreal Bevacizumab
bevacizumab Avastin
Bevacizumab, 1.5 mg, intravitreal, throughout the study
(Experimental)
Treatment of macular edema with intravitreal Ranibizumab
ranibizumab Lucentis
Ranibizumab, 0.5 mg, intravitreal, throughout the study

Primary Outcomes

Measure
Central subfield macular thickness (CSFT) change
time frame: Monthly from baseline to Week 48

Secondary Outcomes

Measure
Best-corrected visual acuity change
time frame: Monthly from baseline to week 48

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
Principal investigator Rodrigo Jorge, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by University of Sao Paulo.