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

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ClinicalTrials.gov 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
Information provided by (Responsible Party):

December 2, 2011
December 7, 2011
December 13, 2011
April 2010
September 2012   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01487629 on ClinicalTrials.gov Archive Site
Best-corrected visual acuity change [ Time Frame: Monthly from baseline to week 48 ]
Best-corrected visual acuity using ETDRS charts
Same as current
Not Provided
Not Provided
Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetic Retinopathy
  • Macular Edema
  • Drug: Bevacizumab
    Bevacizumab, 1.5 mg, intravitreal, throughout the study
    Other Name: Avastin
  • Drug: Ranibizumab
    Ranibizumab, 0.5 mg, intravitreal, throughout the study
    Other Name: Lucentis
  • Experimental: Bevacizumab
    Treatment of macular edema with intravitreal Bevacizumab
    Intervention: Drug: Bevacizumab
  • Experimental: Ranibizumab
    Treatment of macular edema with intravitreal Ranibizumab
    Intervention: Drug: Ranibizumab
Nepomuceno AB, Takaki E, Paes de Almeida FP, Peroni R, Cardillo JA, Siqueira RC, Scott IU, Messias A, Jorge R. A prospective randomized trial of intravitreal bevacizumab versus ranibizumab for the management of diabetic macular edema. Am J Ophthalmol. 2013 Sep;156(3):502-10.e2. doi: 10.1016/j.ajo.2013.04.026. Epub 2013 Jun 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Rodrigo Jorge, University of Sao Paulo
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
University of Sao Paulo
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP