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