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Preoperative Bevacizumab for Vitreous Hemorrhage (IBEVI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596297
First Posted: January 16, 2008
Last Update Posted: October 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
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.

Condition Intervention Phase
Diabetic Retinopathy Vitreous Hemorrhage Drug: bevacizumab Procedure: pars plana vitrectomy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Intra- and postoperative intra-ocular bleeding [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 12 weeks ]

Enrollment: 16
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
Drug: bevacizumab
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline
Other Name: Avastin
Active Comparator: B
Pars plana vitrectomy only
Procedure: pars plana vitrectomy
4 weeks after baseline

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596297


Locations
Brazil
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Daniel R Lucena, MD Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
  More Information

Responsible Party: Daniel da Rocha Lucena, Clinics Hospital of Ribeirão Preto, School of Medicine of Riberião Preto, University of São Paulo
ClinicalTrials.gov Identifier: NCT00596297     History of Changes
Other Study ID Numbers: IBEVI
7309/2007
First Submitted: January 4, 2008
First Posted: January 16, 2008
Last Update Posted: October 3, 2008
Last Verified: September 2008

Keywords provided by University of Sao Paulo:
Diabetic Retinopathy
Vitreous Hemorrhage
Bevacizumab
pars plana vitrectomy
preoperative

Additional relevant MeSH terms:
Hemorrhage
Retinal Diseases
Diabetic Retinopathy
Vitreous Hemorrhage
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage
Bevacizumab
Temazepam
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action