Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

NCT ID: NCT01487629

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Retinopathy Macular Edema

Keywords

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Diabetic Retinopathy Macular Edema Bevacizumab Ranibizumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab

Treatment of macular edema with intravitreal Bevacizumab

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab, 1.5 mg, intravitreal, throughout the study

Ranibizumab

Treatment of macular edema with intravitreal Ranibizumab

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Ranibizumab, 0.5 mg, intravitreal, throughout the study

Interventions

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Bevacizumab

Bevacizumab, 1.5 mg, intravitreal, throughout the study

Intervention Type DRUG

Ranibizumab

Ranibizumab, 0.5 mg, intravitreal, throughout the study

Intervention Type DRUG

Other Intervention Names

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Avastin Lucentis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Jorge

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo Jorge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Felipe Almeida, MD

Role: STUDY_DIRECTOR

Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto

Locations

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

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 23795985 (View on PubMed)

Other Identifiers

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13368/2010

Identifier Type: -

Identifier Source: org_study_id