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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01487629
Recruitment Status : Unknown
Verified December 2011 by Rodrigo Jorge, University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : December 7, 2011
Last Update Posted : December 13, 2011
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Rodrigo Jorge, University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Edema Drug: Bevacizumab Drug: Ranibizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
Study Start Date : April 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Best-corrected visual acuity change [ Time Frame: Monthly from baseline to week 48 ]
    Best-corrected visual acuity using ETDRS charts

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by Rodrigo Jorge, University of Sao Paulo:
Diabetic Retinopathy
Macular Edema

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