A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: Pegaptanib sodium

Participating in This Clinical Trial

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 20/320. – 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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eyetech Pharmaceuticals
  • Collaborator
    • Pfizer

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