Preoperative Bevacizumab for Vitreous Hemorrhage | NCT00596297

Studies
Preoperative Bevacizumab for Vitreous Hemorrhage

NCT00596297

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Oct 3, 2008Estimated

Enrollment

16Actual

Phase

Phase 1Phase 2

Conditions

Diabetic Retinopathy
Vitreous Hemorrhage

Interventions

bevacizumab
pars plana vitrectomy

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
7309/2007

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jan 4, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2008

Last Update Posted Date

Oct 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Preoperative Intravitreal bevacizumab and pars plana vitrectomy	Drug: bevacizumab
B	Active Comparator	Pars plana vitrectomy only	Procedure: pars plana vitrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab	Drug	Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 day after baseline; pars plana vitrectomy 4 weeks after baseline	A

Measure	Description	Time Frame
Intra- and postoperative intra-ocular bleeding		12 weeks

Measure	Description	Time Frame
Visual acuity		12 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel R Lucena, MD	Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP		Ribeirão Preto	São Paulo	14049-900	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy
D014823	Vitreous Hemorrhage

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided