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Clinical Trials/NCT00312351
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)

Eyetech Pharmaceuticals2 sites in 1 country262 target enrollmentStarted: April 2006Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
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

Sponsor Class
Industry

Study Sites (2)

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