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

Phase 3

• Conditions: Electrophysiology

• Registration Number: NCT00533689
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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 available

Study Timeline

• Status Verified: 2007-09
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Last Update Submitted: 2007-09-20
• Study First Posted: 2007-09-21
• Last Update Posted: 2007-09-21
• Study Start: 2008-01
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2008

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel