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

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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Key information

Conditions

Siderosis Lung Diseases Lung Diseases, Interstitial Lung Injury Occupational Diseases Pneumoconiosis Respiratory Tract Diseases

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Trial

Other

No intervention is being used in this study.

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: May 9, 2007
Registry last updated: Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed