A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
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
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 18, 2006
CompletedFirst Posted
Study publicly available on registry
July 20, 2006
CompletedJanuary 15, 2007
January 1, 2007
July 18, 2006
January 12, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subfoveal CNV secondary to AMD
- At least 1 but not more than 3 prior treatments for AMD
You may not qualify if:
- Subfoveal scar or subfoveal atrophy
- Significant media opacities, including cataract, which might interfere with visual acuity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyetech Pharmaceuticalslead
- Pfizercollaborator
Study Sites (1)
Retina Research Institute of Texas, LLC
Abilene, Texas, 79606, United States
Related Publications (1)
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.
PMID: 20472746DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 18, 2006
First Posted
July 20, 2006
Study Start
June 1, 2006
Last Updated
January 15, 2007
Record last verified: 2007-01