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A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354445
Recruitment Status : Unknown
Verified January 2007 by Eyetech Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : July 20, 2006
Last Update Posted : January 15, 2007
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals

Brief Summary:
The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration (AMD) Drug: pegaptanib sodium (Macugen) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement
Study Start Date : June 2006

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Information from the National Library of Medicine

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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:

  • Subfoveal CNV secondary to AMD
  • At least 1 but not more than 3 prior treatments for AMD

Exclusion Criteria:

  • Subfoveal scar or subfoveal atrophy
  • Significant media opacities, including cataract, which might interfere with visual acuity

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): NCT00354445


Contacts
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Contact: Macugen Information 1-866-622-8436

Locations
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United States, Texas
Retina Research Institute of Texas, LLC Recruiting
Abilene, Texas, United States, 79606
Contact: Macugen Information    866-622-8436      
Sponsors and Collaborators
Eyetech Pharmaceuticals
Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00354445    
Other Study ID Numbers: EOP1023
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: January 2007
Keywords provided by Eyetech Pharmaceuticals:
Age-Related Macular Degeneration (AMD)
pegaptanib sodium
subfoveal CNV
macugen
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases