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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT00533689

First received: September 20, 2007

Last updated: NA

Last verified: September 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 20, 2007

Last Updated Date

September 20, 2007

Start Date ^ICMJE

January 2008

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Electrophysiology

Intervention ^ICMJE

Procedure: Electroretinography (ERG), Visual Evoked Potentials (VEP)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

2008

Estimated Completion Date

January 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 90 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact: Michaella Goldstein, MD	+972-3-6925773	michgold@netvision.net.il
Contact: Shiri Soudry, MD	+972-3-6925773	shirizayit@gmail.com

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00533689

Other Study ID Numbers ^ICMJE

TASMC-07-MG-209-CTIL

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Tel-Aviv Sourasky Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Michaella Goldstein, MD	Tel-Aviv Sourasky Medical Center
Study Director:	Anat Loewenstein, MD	Tel-Aviv Sourasky Medical Center
Study Chair:	Ido Perlman, PhD	Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel

Information Provided By

Tel-Aviv Sourasky Medical Center

Verification Date

September 2007

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

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