Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

University of Sao Paulo53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Retinopathy Macular Edema

Interventions

BevacizumabDRUG

Bevacizumab, 1.5 mg, intravitreal, throughout the study

RanibizumabDRUG

Ranibizumab, 0.5 mg, intravitreal, throughout the study

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

Central subfield macular thickness (CSFT) change

Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)

Time frame: Monthly from baseline to Week 48

Secondary Outcomes

Best-corrected visual acuity change

Best-corrected visual acuity using ETDRS charts

Time frame: Monthly from baseline to week 48

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.