Status:
COMPLETED
Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Eyetech Pharmaceuticals
Collaborating Sponsors:
Pfizer
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with...
Eligibility Criteria
Inclusion
- Best corrected visual acuity in the study eye between 20/40 and 20/320.
- Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size \[including blood, scar/atrophy \& neovascularization\] of \< 12 total disc areas, of which at least 50% must be active CNV.
- Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
- General Criteria:
- Patients of either gender, aged greater than 50 years.
- Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
- Written informed consent.
Exclusion
- Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy.
- Patients who are eligible for PDT with Visudyne
- Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00088192
Start Date
July 1 2004
Last Update
August 30 2005
Active Locations (20)
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1
Doheny Eye Institute
Los Angeles, California, United States, 90033
2
Connecticut Retina Consultants, L.L.C.
Bridgeport, Connecticut, United States, 06606
3
New England Retina Associates
Hamden, Connecticut, United States, 06518
4
Retina Health Center
Fort Myers, Florida, United States, 33901