Status:
COMPLETED
Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Eyetech Pharmaceuticals
Collaborating Sponsors:
Pfizer
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in patients with wet AMD.
Detailed Description
This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center and foveal thickness to be treate...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00087763
Start Date
March 1 2004
End Date
May 1 2006
Last Update
May 3 2006
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