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)

Macular Degeneration Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00312351
• Other study ID #: EOP1014
• Status: Terminated
• Phase: Phase 4
• First received: April 6, 2006
• Last updated: January 12, 2007
• Start date: April 2006
• Est. completion date: November 2006

Study information

• Verified date: January 2007
• Source: Eyetech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 262
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Pegaptanib sodium

Locations

Country	Name	City	State
United States	Charlotte Eye, Ear, Nose and Throat Associates, P.A.	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eyetech Pharmaceuticals	Pfizer

Country where clinical trial is conducted

United States,