Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema (IBERA-DME)

December 9, 2011 updated by: Rodrigo Jorge, University of Sao Paulo

Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab
Treatment of macular edema with intravitreal Bevacizumab
Drug: Bevacizumab
Bevacizumab, 1.5 mg, intravitreal, throughout the study
Other Names:
  • Avastin
Experimental: Ranibizumab
Treatment of macular edema with intravitreal Ranibizumab
Drug: Ranibizumab
Ranibizumab, 0.5 mg, intravitreal, throughout the study
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Monthly from baseline to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity change
Time Frame: Monthly from baseline to week 48
Best-corrected visual acuity using ETDRS charts
Monthly from baseline to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Rodrigo Jorge, MD, PhD, University of Sao Paulo
  • Study Director: Felipe Almeida, MD, Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 9, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13368/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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