Study of the Long-Term Effect of Frequent Anti-VEGF Dosin... | NCT00533689

Studies
Study of the Long-Term Effect of Frequent Anti-VEGF Dosing on Retinal Function in Patients With Neovascular AMD

NCT00533689

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Sep 21, 2007Estimated

Enrollment

2,008Estimated

Phase

Phase 3

Conditions

Electrophysiology

Interventions

Electroretinography (ERG), Visual Evoked Potentials (VEP)

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

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Not provided

Completion Date

Jan 2010Estimated

First Submitted Date

Sep 20, 2007

First Submission Date that Met QC Criteria

Sep 20, 2007

First Posted Date

Sep 21, 2007Estimated

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

Sep 20, 2007

Last Update Posted Date

Sep 21, 2007Estimated

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

THis study aims to determine whether frequent dosing of intravitreal injections of Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a deleterious effect on the retina, studied by electrophysiologic testing.

This prospective, non-randomized clinical study will include patients assigned to intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as long as will be deemed necessary. Periodic electrophysiologic evaluation including Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests will be performed every 3 months.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,008Estimated

Name	Type	Description	Arm Group Labels	Other Names
Electroretinography (ERG), Visual Evoked Potentials (VEP)	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of CNV secondary to AMD
No other ocular disease
No history of kerato-refractive surgery
No epilepsy
Ability to perform electrophysiologic study

Exclusion Criteria:

Pregnancy
Minority
Epilepsy
History of kerato-refractive surgery

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michaella Goldstein, MD	Contact	+972-3-6925773		michgold@netvision.net.il
Shiri Soudry, MD	Contact	+972-3-6925773		shirizayit@gmail.com

Overall Officials

Name	Affiliation	Role
Michaella Goldstein, MD	Tel-Aviv Sourasky Medical Center	Principal Investigator
Anat Loewenstein, MD	Tel-Aviv Sourasky Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center		Tel Aviv		64239	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D005074	Evoked Potentials, Visual

Ancestor Terms

ID	Term
D005071	Evoked Potentials
D000071080	Cortical Excitability
D055724	Electrophysiological Phenomena
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided