Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema
This trial is active, not recruiting.
|Conditions||diabetic retinopathy, macular edema|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Central subfield macular thickness (CSFT) change
time frame: Monthly from baseline to Week 48
Best-corrected visual acuity change
time frame: Monthly from baseline to week 48
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
|Official title||Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema|
|Principal investigator||Rodrigo Jorge, MD, PhD|
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