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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00088192
First received: July 21, 2004
Last updated: August 29, 2005
Last verified: August 2005
  Purpose

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.


Condition Intervention
Macular Degeneration
Drug: pegaptanib sodium

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

Resource links provided by NLM:


Further study details as provided by Eyetech Pharmaceuticals:

Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088192

  Hide Study Locations
Locations
United States, California
Doheny Eye Institute
Los Angeles, California, United States, 90033
United States, Connecticut
Connecticut Retina Consultants, L.L.C.
Bridgeport, Connecticut, United States, 06606
New England Retina Associates
Hamden, Connecticut, United States, 06518
United States, Florida
Retina Health Center
Fort Myers, Florida, United States, 33901
United States, Louisiana
Retina Associates
New Orleans, Louisiana, United States, 70155
United States, Maryland
Cumberland Valley Retina Center
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
New England Eye Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Associated Retinal Consultants
Royal Oak, Michigan, United States, 48073
United States, Missouri
Eye Foundation of Kansas City
Kansas City, Missouri, United States, 64108
United States, New Hampshire
The Eye Center of Concord
Concord, New Hampshire, United States, 03301
United States, New Jersey
Vitreo- Retinal Assoc. of NJ
Belleville, New Jersey, United States, 07109
Retina Associates of New Jersey, P.A.
Teaneck, New Jersey, United States, 07666
United States, New York
L.I. Vitreo-Retinal Consultants
Great Neck, New York, United States, 11021
United States, Ohio
Retina Associates of Cleveland Inc.
Lakewood, Ohio, United States, 44107
United States, Oklahoma
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
The Casey Eye Institute
Portland, Oregon, United States, 97239
United States, South Carolina
Palmetto Retina Center
Columbia, South Carolina, United States, 29204
United States, Texas
Valley Retina Associates, P.A.
McAllen, Texas, United States, 78503
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Eyetech Pharmaceuticals
Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00088192     History of Changes
Other Study ID Numbers: EOP1010
Study First Received: July 21, 2004
Last Updated: August 29, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Eyetech Pharmaceuticals:
AMD
Age-Related Macular Degeneration
Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014