Status:
COMPLETED
Study of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Pegaptanib Sodium in Patients With Exudative Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Eyetech Pharmaceuticals
Collaborating Sponsors:
Pfizer
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objectives of this study are to characterize the safety, tolerability and pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6 weeks for 54 weeks in patients ...
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.
- Subfoveal CNV, secondary to AMD, w/ a total lesion size \[including blood, scar/atrophy \& neovascularization\] of less than or equal to 12 disc areas, of which at least 50% must be active CNV.
- Patients of either sex, aged greater than or equal to 50 years.
Exclusion
- Previous subfoveal thermal laser therapy. Any subfoveal scarring or atrophy \& no more than 25% of the total lesion size may be made up of scarring or atrophy.
- More than one prior PDT w/ Visudyne is not permitted. Pts may not have rec'd their 1st PDT w/in less than 8 wks or more than 13 wks prior to the BSL angiography/photography for the study.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00215670
Start Date
November 1 2002
End Date
May 1 2006
Last Update
May 3 2006
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