A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product

Siderosis Clinical Trial

Official title:

A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471224
• Other study ID #: A4321004
• Status: Completed
• Phase: N/A
• First received: May 7, 2007
• Last updated: February 16, 2011
• Start date: June 2007
• Est. completion date: November 2008

Study information

• Verified date: February 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Siderosis

Intervention

Other:
• Observational Trial
No intervention is being used in this study.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follow up for ocular safety and clinical features of ocular siderosis		12 months	Yes
Secondary	ERG changes		12 months	No
Secondary	Anterior segment and fundal photography		12 months	No

External Links

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