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

Completed

• Conditions: Siderosis
• Interventions: Other: Observational Trial

• Registration Number: NCT00471224
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-07
• Study First Submitted QC: 2007-05-07
• Study First Posted: 2007-05-09
• Study Start: 2007-06
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Read More

Exclusion Criteria

None

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who have received drug.	Observational Trial	Patients who have received drug.

Primary Outcome Measures

Name	Time	Method
follow up for ocular safety and clinical features of ocular siderosis	12 months

Secondary Outcome Measures

Name	Time	Method
ERG changes	12 months
Anterior segment and fundal photography	12 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Houston, Texas, United States