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

Primary Purpose

Diabetic Retinopathy, Macular Edema

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Bevacizumab
Ranibizumab
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic Retinopathy, Macular Edema, Bevacizumab, Ranibizumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bevacizumab

Ranibizumab

Arm Description

Treatment of macular edema with intravitreal Bevacizumab

Treatment of macular edema with intravitreal Ranibizumab

Outcomes

Primary Outcome Measures

Central subfield macular thickness (CSFT) change
Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)

Secondary Outcome Measures

Best-corrected visual acuity change
Best-corrected visual acuity using ETDRS charts

Full Information

First Posted
December 2, 2011
Last Updated
December 9, 2011
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01487629
Brief Title
Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema
Acronym
IBERA-DME
Official Title
Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macular Edema
Keywords
Diabetic Retinopathy, Macular Edema, Bevacizumab, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
Treatment of macular edema with intravitreal Bevacizumab
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Treatment of macular edema with intravitreal Ranibizumab
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab, 1.5 mg, intravitreal, throughout the study
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab, 0.5 mg, intravitreal, throughout the study
Primary Outcome Measure Information:
Title
Central subfield macular thickness (CSFT) change
Description
Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)
Time Frame
Monthly from baseline to Week 48
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity change
Description
Best-corrected visual acuity using ETDRS charts
Time Frame
Monthly from baseline to week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Jorge, MD, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felipe Almeida, MD
Organizational Affiliation
Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto
Official's Role
Study Director
Facility Information:
Facility Name
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23795985
Citation
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.
Results Reference
derived

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Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

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