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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Bevacizumab Temazepam

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
A: Experimental 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
B: Active Comparator 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, São Paulo
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:	Clinics Hospital of Ribeirão Preto, School of Medicine of Riberião Preto, University of São Paulo ( Daniel da Rocha Lucena )
Study ID Numbers:	IBEVI, 7309/2007
Study First Received:	January 4, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00596297 History of Changes
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:

Antineoplastic Agents
Growth Substances
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Hemorrhage
Angiogenesis Inhibitors
Vitreous Hemorrhage

Pharmacologic Actions
Diabetic Angiopathies
Diabetic Retinopathy
Pathologic Processes
Therapeutic Uses
Eye Hemorrhage
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on February 08, 2010