Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)

Completed · Not applicable

Conditions studied: Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00088192

Run by

Eyetech Pharmaceuticals

Starts

2004-07-01

Last updated by the study team

2005-08-30

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Doheny Eye Institute — Los Angeles, California, United States
• Connecticut Retina Consultants, L.L.C. — Bridgeport, Connecticut, United States
• New England Retina Associates — Hamden, Connecticut, United States
• Retina Health Center — Fort Myers, Florida, United States
• Retina Associates — New Orleans, Louisiana, United States
• Cumberland Valley Retina Center — Hagerstown, Maryland, 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
• Eye Foundation of Kansas City — Kansas City, Missouri, United States
• The Eye Center of Concord — Concord, New Hampshire, United States
• Vitreo- Retinal Assoc. of NJ — Belleville, New Jersey, United States
• Retina Associates of New Jersey, P.A. — Teaneck, New Jersey, United States
• L.I. Vitreo-Retinal Consultants — Great Neck, New York, United States
• Retina Associates of Cleveland Inc. — Lakewood, Ohio, United States
• Dean A. McGee Eye Institute — Oklahoma City, Oklahoma, United States
• The Casey Eye Institute — Portland, Oregon, United States
• Palmetto Retina Center — Columbia, South Carolina, United States
• Valley Retina Associates, P.A. — McAllen, Texas, United States
• University of Vermont College of Medicine — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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