Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00471224
Other study ID # A4321004
Secondary ID
Status Completed
Phase N/A
First received May 7, 2007
Last updated February 16, 2011
Start date June 2007
Est. completion date November 2008

Study information

Verified date February 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 55 Years to 90 Years
Eligibility 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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Observational Trial
No intervention is being used in this study.

Locations

Country Name City State
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary follow up for ocular safety and clinical features of ocular siderosis 12 months Yes
Secondary ERG changes 12 months No
Secondary Anterior segment and fundal photography 12 months No
See also
  Status Clinical Trial Phase
Completed NCT05394636 - Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy
Completed NCT04200664 - Audiovestibular Function in Infratentorial Superficial Siderosis