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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00471224

Enrollment

Registered

2007-05-09

Start date

2007-06-30

Completion date

2008-11-30

Last updated

2011-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Siderosis

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).

Interventions

OTHERObservational Trial

No intervention is being used in this study.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
follow up for ocular safety and clinical features of ocular siderosis	12 months

Secondary

Measure	Time frame
ERG changes	12 months
Anterior segment and fundal photography	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026