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

This study has been completed.
Information provided by:
Eyetech Pharmaceuticals Identifier:
First received: July 13, 2004
Last updated: May 2, 2006
Last verified: May 2006
The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in patients with wet AMD.

Condition Intervention Phase
Macular Degeneration
Drug: Macugen ™ (pegaptanib sodium injection)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment: 135
Study Start Date: March 2004
Estimated Study Completion Date: May 2006
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.

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 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
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No Contacts or Locations Provided
  More Information Identifier: NCT00087763     History of Changes
Other Study ID Numbers: EOP 1009
Study First Received: July 13, 2004
Last Updated: May 2, 2006

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
Retinal Degeneration
Retinal Diseases
Eye Diseases processed this record on April 27, 2017