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

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.

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Detailed Description

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Conditions

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Diabetic Retinopathy Retinal Detachment

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