Preoperative Bevacizumab for Vitreous Hemorrhage

Overview

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.

Full Title of Study: “Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2008

Interventions

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

Arms, Groups and Cohorts

  • Experimental: A
    • Preoperative Intravitreal bevacizumab and pars plana vitrectomy
  • Active Comparator: B
    • Pars plana vitrectomy only

Clinical Trial Outcome Measures

Primary Measures

  • Intra- and postoperative intra-ocular bleeding
    • Time Frame: 12 weeks

Secondary Measures

  • Visual acuity
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Daniel da Rocha Lucena, Clinics Hospital of Ribeirão Preto, School of Medicine of Riberião Preto, University of São Paulo
  • Overall Official(s)
    • Daniel R Lucena, MD, Principal Investigator, Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

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