Clinical Trial: A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).
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 Summary:
Sponsor: Pfizer
Current Primary Outcome: follow up for ocular safety and clinical features of ocular siderosis [ Time Frame: 12 months ]
Original Primary Outcome:
Current Secondary Outcome:
- ERG changes [ Time Frame: 12 months ]
- Anterior segment and fundal photography [ Time Frame: 12 months ]
Original Secondary Outcome:
Information By: Pfizer
Dates:
Date Received: May 7, 2007
Date Started: June 2007
Date Completion:
Last Updated: February 16, 2011
Last Verified: February 2011