Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
- Conditions
- Macular Degeneration
- Registration Number
- NCT00088192
- Lead Sponsor
- Eyetech Pharmaceuticals
- 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 this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Eye Foundation of Kansas City
🇺🇸Kansas City, Missouri, United States
The Eye Center of Concord
🇺🇸Concord, New Hampshire, United States
Retina Associates of Cleveland Inc.
🇺🇸Lakewood, Ohio, United States
Valley Retina Associates, P.A.
🇺🇸McAllen, Texas, United States
Cumberland Valley Retina Center
🇺🇸Hagerstown, Maryland, United States
Doheny Eye Institute
🇺🇸Los Angeles, California, United States
Connecticut Retina Consultants, L.L.C.
🇺🇸Bridgeport, Connecticut, United States
Retina Health Center
🇺🇸Fort Myers, Florida, United States
New England Eye Center
🇺🇸Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Associated Retinal Consultants
🇺🇸Royal Oak, Michigan, United States
L.I. Vitreo-Retinal Consultants
🇺🇸Great Neck, New York, United States
Palmetto Retina Center
🇺🇸Columbia, South Carolina, United States
University of Vermont College of Medicine
🇺🇸Burlington, Vermont, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
The Casey Eye Institute
🇺🇸Portland, Oregon, United States
New England Retina Associates
🇺🇸Hamden, Connecticut, United States
Vitreo- Retinal Assoc. of NJ
🇺🇸Belleville, New Jersey, United States
Retina Associates
🇺🇸New Orleans, Louisiana, United States
Retina Associates of New Jersey, P.A.
🇺🇸Teaneck, New Jersey, United States