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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

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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