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OpenTrials
Completed

NCT Number: NCT00596297

Preoperative Bevacizumab for Vitreous Hemorrhage

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.

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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 Diseases Vascular Diseases Vitreous Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / 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

  • 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

Treatment and study plan

Bevacizumab

Drug

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

Other names: Avastin

pars plana vitrectomy

Procedure

4 weeks after baseline

Primary outcomes

  1. Intra- and postoperative intra-ocular bleeding

    Time frame: 12 weeks

Secondary outcomes

  1. Visual acuity

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab

Acronym: IBEVI

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 16, 2008
Registry last updated
Oct 3, 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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