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A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)

This study has been terminated.
Information provided by:
Eyetech Pharmaceuticals Identifier:
First received: April 6, 2006
Last updated: January 12, 2007
Last verified: January 2007
The purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD. The study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.

Condition Intervention Phase
Macular Degeneration Drug: Pegaptanib sodium Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Exploratory Randomized, Double-Masked, Multi-Center Comparative Trial, in Parallel Groups, to Explore the Safety and Efficacy of Three Different Doses of Intravitreous Injections of Pegaptanib Sodium (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 102 Weeks, in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:

Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment: 262
Study Start Date: April 2006
Estimated Study Completion Date: November 2006

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

Inclusion Criteria:

  • Subjects of either gender, aged 50 years or greater.
  • Subfoveal choroidal neovascularization (CNV) due to AMD.
  • Best corrected visual acuity in the study eye between 20/40 and 20/320.
  • Normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more.

Exclusion Criteria:

  • Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00312351

United States, North Carolina
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
Charlotte, North Carolina, United States, 28210
Sponsors and Collaborators
Eyetech Pharmaceuticals
  More Information Identifier: NCT00312351     History of Changes
Other Study ID Numbers: EOP1014
Study First Received: April 6, 2006
Last Updated: January 12, 2007

Keywords provided by Eyetech Pharmaceuticals:
Age-Related Macular Degeneration
Macular Degeneration
pegaptanib sodium
specular microscopy
Age-Related Mcular Degeneration (AMD)

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases processed this record on August 22, 2017