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

Electrophysiology Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00533689
• Other study ID #: TASMC-07-MG-209-CTIL
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 20, 2007
• Last updated: September 20, 2007
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: September 2007
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Michaella Goldstein, MD
• Phone: +972-3-6925773
• Email: michgold[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2008
• Est. completion date: January 2010
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Electrophysiology

Intervention

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

Locations

Country	Name	City	State
Israel	Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel,