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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)

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ClinicalTrials.gov Identifier: NCT00312351
Recruitment Status : Terminated
First Posted : April 10, 2006
Last Update Posted : January 15, 2007
Information provided by:
Eyetech Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Macular Degeneration Drug: Pegaptanib sodium Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
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)
Study Start Date : April 2006
Estimated Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00312351     History of Changes
Other Study ID Numbers: EOP1014
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: January 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