NCT00533689UnknownPhase 3
Study of the Long-Term Effect of Frequent Anti-VEGF Dosing on Retinal Function in Patients With Neovascular AMD
Tel-Aviv Sourasky Medical Center1 site in 1 country2,008 target enrollmentStarted: January 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 2,008
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •History of kerato-refractive surgery
Investigators
Study Sites (1)
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