Study of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Pegaptanib Sodium in Patients With Exudative Age-Related Macular Degeneration (AMD)
A Randomized, Double-Masked, Multi-Center Trial of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Intravitreal Injections of Pegaptanib Sodium (Anti-Vegf Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients With Exudative Age-Related Macular Degeneration (AMD)
1 other identifier
interventional
125
0 countries
N/A
Brief Summary
The objectives of this study are to characterize the safety, tolerability and pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6 weeks for 54 weeks in patients with subfoveal choroidal neovascularization (CNV) secondary to AMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2002
Typical duration for phase_2
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
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedMay 3, 2006
May 1, 2006
September 14, 2005
May 2, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye.
- Subfoveal CNV, secondary to AMD, w/ a total lesion size \[including blood, scar/atrophy \& neovascularization\] of less than or equal to 12 disc areas, of which at least 50% must be active CNV.
- Patients of either sex, aged greater than or equal to 50 years.
You may not qualify if:
- Previous subfoveal thermal laser therapy. Any subfoveal scarring or atrophy \& no more than 25% of the total lesion size may be made up of scarring or atrophy.
- More than one prior PDT w/ Visudyne is not permitted. Pts may not have rec'd their 1st PDT w/in less than 8 wks or more than 13 wks prior to the BSL angiography/photography for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyetech Pharmaceuticalslead
- Pfizercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
November 1, 2002
Study Completion
May 1, 2006
Last Updated
May 3, 2006
Record last verified: 2006-05