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Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
This study has been completed.
Sponsors and Collaborators: Eyetech Pharmaceuticals
Pfizer
Information provided by: Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00088192
  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

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Dietary Sodium Macular Degeneration
Drug Information available for: Pegaptanib sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

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

  Show 20 Study Locations
Sponsors and Collaborators
Eyetech Pharmaceuticals
Pfizer
  More Information

Sponsors Website  This link exits the ClinicalTrials.gov site

Study ID Numbers: EOP1010
Study First Received: July 21, 2004
Last Updated: August 29, 2005
ClinicalTrials.gov Identifier: NCT00088192  
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

Study placed in the following topic categories:
Eye Diseases
Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

ClinicalTrials.gov processed this record on January 14, 2009