Clinical trial NCT00088192: Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Keywords: AMD
Age-Related Macular Degeneration
Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2004-07-22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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