A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product
February 16, 2011 updated by: Pfizer
A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).
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).
Study Overview
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28210
- Pfizer Investigational Site
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Texas
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Houston, Texas, United States, 77030
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A subset of subjects enrolled in study A4321001 and who have received formulated drug product.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients who have received drug.
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No intervention is being used in this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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follow up for ocular safety and clinical features of ocular siderosis
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ERG changes
Time Frame: 12 months
|
12 months
|
|
Anterior segment and fundal photography
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
May 7, 2007
First Submitted That Met QC Criteria
May 7, 2007
First Posted (Estimate)
May 9, 2007
Study Record Updates
Last Update Posted (Estimate)
February 17, 2011
Last Update Submitted That Met QC Criteria
February 16, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4321004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.