Preoperative Bevacizumab for Vitreous Hemorrhage - Full Text View

Sponsor:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00596297

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

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 22, 2012