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

Macular Degeneration Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088192
• Other study ID #: EOP1010
• Status: Completed
• Phase: N/A
• First received: July 21, 2004
• Last updated: August 29, 2005
• Start date: July 2004

Study information

• Verified date: August 2005
• Source: Eyetech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• pegaptanib sodium

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Eyetech Pharmaceuticals	Pfizer

Country where clinical trial is conducted

United States, 

External Links

•   Sponsors Website