NCT00312351TerminatedPhase 4
An Exploratory Randomized, Double-Masked, Multi-Center Comparative Trial, in Parallel Groups, to Explore the Safety and Efficacy of Three Different Doses of Intravitreous Injections of Pegaptanib Sodium (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 102 Weeks, in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (AMD)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Eyetech Pharmaceuticals
- Enrollment
- 262
- Locations
- 2
Study Overview
Brief Summary
The purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD. The study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects of either gender, aged 50 years or greater.
- •Subfoveal choroidal neovascularization (CNV) due to AMD.
- •Best corrected visual acuity in the study eye between 20/40 and 20/
- •Normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more.
Exclusion Criteria
- •Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.
Investigators
Study Sites (2)
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