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Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)

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ClinicalTrials.gov Identifier: NCT00087763
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : May 3, 2006
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals

Brief Summary:
The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in patients with wet AMD.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Macugen ™ (pegaptanib sodium injection) Phase 2

Detailed Description:
This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center and foveal thickness to be treated either Macugen or a sham injection. After 24 weeks, all patients will treated with Macugen until the end of the study at 54 weeks.

Study Type : Interventional  (Clinical Trial)
Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II Prospective, Randomized, Double-Masked, Sham-Controlled, Dose-Ranging, Multi-Center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)
Study Start Date : March 2004
Study Completion Date : May 2006

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.
  • Foveal thickness <= 300 um (measured by OCT center point thickness).
  • Subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy & neovascularization) of <= 12 disc areas, of which at least 50% must be active CNV.

Exclusion Criteria:

  • Previous subfoveal thermal laser therapy.
  • Any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. Additionally no more than 25% of the total lesion size may be made up of scarring or atrophy.
  • Previous photodynamic therapy with Visudyne (PDT) in the study eye. Eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, PDT can be deferred for at least 54 weeks after the first study treatment

ClinicalTrials.gov Identifier: NCT00087763     History of Changes
Other Study ID Numbers: EOP 1009
First Posted: July 16, 2004    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: May 2006

Keywords provided by Eyetech Pharmaceuticals:
AMD
Age Related Macular Degeneration
Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases