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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Rodrigo Jorge, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01487629
First received: December 2, 2011
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
Macular Edema
 Drug: Bevacizumab
Drug: Ranibizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Central subfield macular thickness (CSFT) change [ Time Frame: Monthly from baseline to Week 48 ] [ Designated as safety issue: No ]
    Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)


Secondary Outcome Measures:
  • Best-corrected visual acuity change [ Time Frame: Monthly from baseline to week 48 ] [ Designated as safety issue: No ]
    Best-corrected visual acuity using ETDRS charts


Enrollment: 53
Study Start Date: April 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Treatment of macular edema with intravitreal Bevacizumab
 Drug: Bevacizumab
Bevacizumab, 1.5 mg, intravitreal, throughout the study
Other Name: Avastin
Experimental: Ranibizumab
Treatment of macular edema with intravitreal Ranibizumab
 Drug: Ranibizumab
Ranibizumab, 0.5 mg, intravitreal, throughout the study
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487629

Locations
Brazil
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Rodrigo Jorge, MD, PhD University of São Paulo
Study Director: Felipe Almeida, MD Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto
  More Information

No publications provided

Responsible Party: Rodrigo Jorge, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01487629     History of Changes
Other Study ID Numbers: 13368/2010
Study First Received: December 2, 2011
Last Updated: December 9, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Diabetic Retinopathy
Macular Edema
Bevacizumab
Ranibizumab

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
 Macular Degeneration
Retinal Degeneration
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013