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

This study has been completed.
Information provided by:
Eyetech Pharmaceuticals Identifier:
First received: July 21, 2004
Last updated: August 29, 2005
Last verified: August 2005
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
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)

Resource links provided by NLM:

Further study details as provided by Eyetech Pharmaceuticals:

Study Start Date: July 2004

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00088192

  Show 20 Study Locations
Sponsors and Collaborators
Eyetech Pharmaceuticals
  More Information Identifier: NCT00088192     History of Changes
Other Study ID Numbers: EOP1010
Study First Received: July 21, 2004
Last Updated: August 29, 2005

Keywords provided by Eyetech Pharmaceuticals:
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 processed this record on September 21, 2017