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Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)

NCT ID: NCT00690768

Last Updated: 2008-06-05

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

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.

Detailed Description

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Conditions

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Diabetic Retinopathy Retinal Detachment

Keywords

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Diabetic Retinopathy Retinal detachment Vitreous Hemorrhage Bevacizumab preoperative pars plana vitrectomy

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 week after baseline; pars plana vitrectomy 3 weeks after baseline

pars plana vitrectomy

Intervention Type PROCEDURE

pars plana vitrectomy 3 weeks after baseline

B

Pars plana vitrectomy only

Group Type ACTIVE_COMPARATOR

pars plana vitrectomy

Intervention Type PROCEDURE

pars plana vitrectomy 3 weeks after baseline

Interventions

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Bevacizumab

Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline

Intervention Type DRUG

pars plana vitrectomy

pars plana vitrectomy 3 weeks after baseline

Intervention Type PROCEDURE

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria

* Massive vitreous hemorrhage preventing from detailed posterior pole examination;
* Previous intra-ocular surgery other than cataract surgery
* Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
* Prothrombin time, partial thromboplastin time or platelet count without normal limits
* History of previous thromboembolic events
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

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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da R Lucena D, Ribeiro JA, Costa RA, Barbosa JC, Scott IU, de Figueiredo-Pontes LL, Jorge R. Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IBeTra study). Br J Ophthalmol. 2009 May;93(5):688-91. doi: 10.1136/bjo.2008.151233. Epub 2009 Feb 10.

Reference Type DERIVED
PMID: 19208678 (View on PubMed)

Other Identifiers

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IBETRA

Identifier Type: -

Identifier Source: org_study_id