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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533689
First Posted: September 21, 2007
Last Update Posted: September 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose

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.


Condition Intervention Phase
Electrophysiology Procedure: Electroretinography (ERG), Visual Evoked Potentials (VEP) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 2008
Study Start Date: January 2008
Estimated Study Completion Date: January 2010
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533689


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

Locations
Israel
Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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
  More Information

ClinicalTrials.gov Identifier: NCT00533689     History of Changes
Other Study ID Numbers: TASMC-07-MG-209-CTIL
First Submitted: September 20, 2007
First Posted: September 21, 2007
Last Update Posted: September 21, 2007
Last Verified: September 2007