Preoperative Bevacizumab for Vitreous Hemorrhage - Tabular View

Tracking Information

First Received Date ^ICMJE

January 4, 2008

Last Updated Date

October 2, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00596297 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Visual acuity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Preoperative Bevacizumab for Vitreous Hemorrhage

Official Title ^ICMJE

Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab

Brief Summary

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Retinopathy
Vitreous Hemorrhage

Intervention ^ICMJE

Drug: bevacizumab
Procedure: pars plana vitrectomy

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00596297

Responsible Party

Daniel da Rocha Lucena, Clinics Hospital of Ribeirão Preto, School of Medicine of Riberião Preto, University of São Paulo

Study ID Numbers ^ICMJE

IBEVI, 7309/2007

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Daniel R Lucena, MD

Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP

Information Provided By

University of Sao Paulo

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP