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

Pfizer16 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Siderosis

Interventions

Observational TrialOTHER

No intervention is being used in this study.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (3)

Pfizer Investigational Site

Boston, Massachusetts, United States

Pfizer Investigational Site

Charlotte, North Carolina, United States

Pfizer Investigational Site

Houston, Texas, United States

Outcomes

Primary Outcomes

follow up for ocular safety and clinical features of ocular siderosis

Time frame: 12 months

Secondary Outcomes

ERG changes

Time frame: 12 months

Anterior segment and fundal photography

Time frame: 12 months

Data from ClinicalTrials.gov

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