Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
An Open Label, Non-Comparative Protocol for Use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD)
1 other identifier
interventional
N/A
1 country
20
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.
Trial Health
Trial Health Score
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20 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 21, 2004
CompletedFirst Posted
Study publicly available on registry
July 22, 2004
CompletedAugust 30, 2005
August 1, 2005
July 21, 2004
August 29, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyetech Pharmaceuticalslead
- Pfizercollaborator
Study Sites (20)
Doheny Eye Institute
Los Angeles, California, 90033, United States
Connecticut Retina Consultants, L.L.C.
Bridgeport, Connecticut, 06606, United States
New England Retina Associates
Hamden, Connecticut, 06518, United States
Retina Health Center
Fort Myers, Florida, 33901, United States
Retina Associates
New Orleans, Louisiana, 70155, United States
Cumberland Valley Retina Center
Hagerstown, Maryland, 21740, United States
New England Eye Center
Boston, Massachusetts, 02111, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Associated Retinal Consultants
Royal Oak, Michigan, 48073, United States
Eye Foundation of Kansas City
Kansas City, Missouri, 64108, United States
The Eye Center of Concord
Concord, New Hampshire, 03301, United States
Vitreo- Retinal Assoc. of NJ
Belleville, New Jersey, 07109, United States
Retina Associates of New Jersey, P.A.
Teaneck, New Jersey, 07666, United States
L.I. Vitreo-Retinal Consultants
Great Neck, New York, 11021, United States
Retina Associates of Cleveland Inc.
Lakewood, Ohio, 44107, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
The Casey Eye Institute
Portland, Oregon, 97239, United States
Palmetto Retina Center
Columbia, South Carolina, 29204, United States
Valley Retina Associates, P.A.
McAllen, Texas, 78503, United States
University of Vermont College of Medicine
Burlington, Vermont, 05401, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 21, 2004
First Posted
July 22, 2004
Study Start
July 1, 2004
Last Updated
August 30, 2005
Record last verified: 2005-08