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Completed

NCT Number: NCT00690768

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

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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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Eye Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Detachment Retinal Diseases Vascular Diseases Vitreous Hemorrhage

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Other names: Avastin

pars plana vitrectomy

Procedure

pars plana vitrectomy 3 weeks after baseline

Primary outcomes

  1. amount of intraoperative intra-ocular bleeding

    Time frame: three weeks

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: IBETRA

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 5, 2008
Registry last updated
Jun 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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