Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema
IBERA-DME
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 2, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedDecember 13, 2011
December 1, 2011
2.4 years
December 2, 2011
December 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Central subfield macular thickness (CSFT) change
Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)
Monthly from baseline to Week 48
Secondary Outcomes (1)
Best-corrected visual acuity change
Monthly from baseline to week 48
Study Arms (2)
Bevacizumab
EXPERIMENTALTreatment of macular edema with intravitreal Bevacizumab
Ranibizumab
EXPERIMENTALTreatment of macular edema with intravitreal Ranibizumab
Interventions
Bevacizumab, 1.5 mg, intravitreal, throughout the study
Ranibizumab, 0.5 mg, intravitreal, throughout the study
Eligibility Criteria
You may qualify if:
- Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
- Central subfield macular thickness greater than 300 µm
You may not qualify if:
- Aphakia
- High-risk proliferative diabetic retinopathy
- Previous treatment for DME in the past three months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Ribeirão Preto, São Paulo, 14048-900, Brazil
Related Publications (1)
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):502-510.e2. doi: 10.1016/j.ajo.2013.04.026. Epub 2013 Jun 21.
PMID: 23795985DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodrigo Jorge, MD, PhD
University of Sao Paulo
- STUDY DIRECTOR
Felipe Almeida, MD
Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 2, 2011
First Posted
December 7, 2011
Study Start
April 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 13, 2011
Record last verified: 2011-12