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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Rodrigo Jorge, University of Sao Paulo.
Recruitment status was:  Active, not recruiting
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
  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
Intervention Model: Parallel Assignment
Masking: None (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 Rodrigo Jorge, University of Sao Paulo:

Primary Outcome Measures:
  • 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:
  • Best-corrected visual acuity change [ Time Frame: Monthly from baseline to week 48 ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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

Additional relevant MeSH terms:
Edema
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
Bevacizumab
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 17, 2017