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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088192
Recruitment Status : Completed
First Posted : July 22, 2004
Last Update Posted : August 30, 2005
Information provided by:
Eyetech Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: pegaptanib sodium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2004

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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088192

  Hide Study Locations
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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
New England Eye Center
Boston, Massachusetts, United States, 02111
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
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

Layout table for additonal information Identifier: NCT00088192     History of Changes
Other Study ID Numbers: EOP1010
First Posted: July 22, 2004    Key Record Dates
Last Update Posted: August 30, 2005
Last Verified: August 2005
Keywords provided by Eyetech Pharmaceuticals:
Age-Related Macular Degeneration
Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases