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

Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Retinopathy; Retinal Detachment

Intervention: Bevacizumab (Drug); pars plana vitrectomy (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: University of Sao Paulo

Summary

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.

Clinical Details

Official title: Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: amount of intraoperative intra-ocular bleeding

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP, Ribeirão Preto, São Paulo 14049-900, Brazil
Additional Information

Starting date: March 2008
Ending date: May 2008
Last updated: June 3, 2008

Page last updated: June 20, 2008

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