Trial record 19 of 1213 for:    "Macular Degeneration"

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT00088192

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Sponsors and Collaborators
Eyetech Pharmaceuticals
  More Information

Additional Information: Identifier: NCT00088192     History of Changes
Other Study ID Numbers: EOP1010 
Study First Received: July 21, 2004
Last Updated: August 29, 2005
Health Authority: United States: Food and Drug Administration

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
Eye Diseases
Retinal Degeneration
Retinal Diseases processed this record on May 26, 2016