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Preoperative Bevacizumab for Vitreous Hemorrhage

NCT ID: NCT00596297

Last Updated: 2008-10-03

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.

Detailed Description

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Conditions

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Diabetic Retinopathy Vitreous Hemorrhage

Keywords

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Diabetic Retinopathy Vitreous Hemorrhage Bevacizumab pars plana vitrectomy preoperative

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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A

Preoperative Intravitreal bevacizumab and pars plana vitrectomy

Group Type EXPERIMENTAL

bevacizumab

Intervention Type DRUG

Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline

B

Pars plana vitrectomy only

Group Type ACTIVE_COMPARATOR

pars plana vitrectomy

Intervention Type PROCEDURE

4 weeks after baseline

Interventions

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bevacizumab

Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline

Intervention Type DRUG

pars plana vitrectomy

4 weeks after baseline

Intervention Type PROCEDURE

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Diabetic retinopathy causing significant vitreous hemorrhage with visual acuity loss lasting more than three months in patients not previously treated and four months in those previously LASER treated.

Exclusion Criteria

* Previous intra-ocular surgery other than cataract surgery
* Retinal detachment
* Use of anticoagulants drugs other than aspirin
* Vitreous hemorrhage clearance at week-3 study period
* History of previous thromboembolic events
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Clinics Hospital of Ribeirão Preto, School of Medicine of Riberião Preto, University of São Paulo

Principal Investigators

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Daniel R Lucena, MD

Role: PRINCIPAL_INVESTIGATOR

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

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

Other Identifiers

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7309/2007

Identifier Type: -

Identifier Source: secondary_id

IBEVI

Identifier Type: -

Identifier Source: org_study_id