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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Siderosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who have received drug.

Observational Trial

Intervention Type OTHER

No intervention is being used in this study.

Interventions

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Observational Trial

No intervention is being used in this study.

Intervention Type OTHER

Eligibility Criteria

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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.