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

July 21, 2004
August 29, 2005
July 2004
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Complete list of historical versions of study NCT00088192 on ClinicalTrials.gov Archive Site
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Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
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)

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.

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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Macular Degeneration
Drug: pegaptanib sodium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00088192
EOP1010
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Eyetech Pharmaceuticals
Pfizer
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Eyetech Pharmaceuticals
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP