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)

NCT ID: NCT00312351

Last Updated: 2007-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-11-30

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.

Conditions

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Pegaptanib sodium

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Eyetech Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

Charlotte Eye, Ear, Nose and Throat Associates, P.A.

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

EOP1014

Identifier Type: -

Identifier Source: org_study_id