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
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

December 2, 2011
December 9, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
53
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01487629
13368/2010
No
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