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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 3

Conditions: Electrophysiology

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00533689

TASMC-07-MG-209-CTIL

Details and patient eligibility

About

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.

Enrollment: 2,008 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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