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)
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)
1 other identifier
interventional
262
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 6, 2006
CompletedFirst Posted
Study publicly available on registry
April 10, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJanuary 15, 2007
January 1, 2007
April 6, 2006
January 12, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyetech Pharmaceuticalslead
- Pfizercollaborator
Study Sites (1)
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
Charlotte, North Carolina, 28210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 6, 2006
First Posted
April 10, 2006
Study Start
April 1, 2006
Study Completion
November 1, 2006
Last Updated
January 15, 2007
Record last verified: 2007-01