Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)
A Phase II Prospective, Randomized, Double-Masked, Sham-Controlled, Dose-Ranging, Multi-Center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)
1 other identifier
interventional
135
0 countries
N/A
Brief Summary
The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in 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_2
Started Mar 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 13, 2004
CompletedFirst Posted
Study publicly available on registry
July 16, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedMay 3, 2006
May 1, 2006
July 13, 2004
May 2, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.
- Foveal thickness \<= 300 um (measured by OCT center point thickness).
- Subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy \& neovascularization) of \<= 12 disc areas, of which at least 50% must be active CNV.
You may not qualify if:
- Previous subfoveal thermal laser therapy.
- Any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. Additionally no more than 25% of the total lesion size may be made up of scarring or atrophy.
- Previous photodynamic therapy with Visudyne (PDT) in the study eye. Eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, PDT can be deferred for at least 54 weeks after the first study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyetech Pharmaceuticalslead
- Pfizercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2004
First Posted
July 16, 2004
Study Start
March 1, 2004
Study Completion
May 1, 2006
Last Updated
May 3, 2006
Record last verified: 2006-05