A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product
1 other identifier
observational
16
1 country
3
Brief Summary
This protocol intends to detail investigations necessary to evaluate the ocular safety of subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot 8716-098).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2007
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2007
CompletedFirst Posted
Study publicly available on registry
May 9, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFebruary 17, 2011
February 1, 2011
1.4 years
May 7, 2007
February 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
follow up for ocular safety and clinical features of ocular siderosis
12 months
Secondary Outcomes (2)
ERG changes
12 months
Anterior segment and fundal photography
12 months
Study Arms (1)
Patients who have received drug.
Patients who have received drug.
Interventions
No intervention is being used in this study.
Eligibility Criteria
A subset of subjects enrolled in study A4321001 and who have received formulated drug product.
You may qualify if:
- A subset of subjects enrolled in study A4321001 and who have received formulated drug product (Lot 8716-098) will be included in the safety follow up study.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Pfizer Investigational Site
Boston, Massachusetts, 02114, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28210, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2007
First Posted
May 9, 2007
Study Start
June 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
February 17, 2011
Record last verified: 2011-02