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.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00312351
First received: April 6, 2006
Last updated: January 12, 2007
Last verified: January 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312351

Locations
United States, North Carolina
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
Charlotte, North Carolina, United States, 28210
Sponsors and Collaborators
Eyetech Pharmaceuticals
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312351     History of Changes
Other Study ID Numbers: EOP1014
Study First Received: April 6, 2006
Last Updated: January 12, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014