Bevacizumab Effect on Blood Velocity | NCT01298440

Studies
Bevacizumab Effect on Blood Velocity

NCT01298440

Sponsor

Optical Imaging, Ltd.

Status

Completed

Last Update Posted

Feb 17, 2011Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Choroidal Neovascularization

Interventions

Not provided

Countries

Israel

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

Status Module

Record Verification Date

Feb 2011

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

Jan 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Feb 16, 2011

First Submission Date that Met QC Criteria

Feb 16, 2011

First Posted Date

Feb 17, 2011Estimated

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

Feb 16, 2011

Last Update Posted Date

Feb 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is correlated to treatment success.

Detailed Description

The purpose of the study was to carry out a pilot study on the short-term effect of intravitreal Bevacizumab (Avastin) injection on retinal blood-flow velocity and test whether the short-term haemodynamic changes could predict the longer term clinical result of the treatment.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Measure	Description	Time Frame
Blood flow velocity change		1 day following injection

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with CNV receiving Bevacizumab intravitreal injection

Exclusion Criteria:

Candidates in whom the retina could not be seen clearly because of media opacity or a poorly dilating pupil

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with choroidal neovascularization (CNV)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adiel Barak, MD	Tel aviv university Sackler school of medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel aviv sourasky medical center		Tel Aviv		64239	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23418734	Derived	Burgansky-Eliash Z, Lowenstein A, Neuderfer M, Kesler A, Barash H, Nelson DA, Grinvald A, Barak A. The correlation between retinal blood flow velocity measured by the retinal function imager and various physiological parameters. Ophthalmic Surg Lasers Imaging Retina. 2013 Jan-Feb;44(1):51-8. doi: 10.3928/23258160-20121221-13.

ID	Term
D015862	Choroid Diseases
D014603	Uveal Diseases
D005128	Eye Diseases
D009389	Neovascularization, Pathologic