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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Rodrigo Jorge, University of Sao Paulo Identifier:
First received: December 2, 2011
Last updated: December 9, 2011
Last verified: December 2011
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:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01487629

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
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 by University of Sao Paulo

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rodrigo Jorge, Principal investigator, University of Sao Paulo 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

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Edema
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Signs and Symptoms
Vascular Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 04, 2016