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Preoperative Bevacizumab for Vitreous Hemorrhage (IBEVI)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00596297
First received: January 4, 2008
Last updated: October 2, 2008
Last verified: September 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Intra- and postoperative intra-ocular bleeding [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 4, 2008
Last Updated: October 2, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on May 23, 2013