Back to resultsA Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
Primary Purpose
Age-Related Macular Degeneration (AMD)
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pegaptanib sodium (Macugen)
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration (AMD) focused on measuring Age-Related Macular Degeneration (AMD), pegaptanib sodium, subfoveal CNV, macugen
Eligibility 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
Sites / Locations
- Retina Research Institute of Texas, LLCRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00354445
First Posted
July 18, 2006
Last Updated
January 12, 2007
Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00354445
Brief Title
A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
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 Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration (AMD)
Keywords
Age-Related Macular Degeneration (AMD), pegaptanib sodium, subfoveal CNV, macugen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium (Macugen)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Macugen Information
Phone
1-866-622-8436
Facility Information:
Facility Name
Retina Research Institute of Texas, LLC
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Macugen Information
Phone
866-622-8436
12. IPD Sharing Statement
Citations:
PubMed Identifier
20472746
Citation
Friberg TR, Tolentino M; LEVEL Study Group; Weber P, Patel S, Campbell S, Goldbaum M. Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study. Br J Ophthalmol. 2010 Dec;94(12):1611-7. doi: 10.1136/bjo.2009.174946. Epub 2010 May 14.
Results Reference
derived
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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
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