A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

This study is currently recruiting participants.

Verified by Pfizer, January 2010

First Received: September 22, 2008 Last Updated: January 29, 2010 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00759174

Purpose

The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.

Condition	Phase
Optic Neuropathy, Ischemic	Phase IV

Study Type:	Observational
Study Design:	Case-Crossover, Retrospective
Official Title:	Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

Further study details as provided by Pfizer:

Primary Outcome Measures:

Acute NAION is the sole endpoint of interest in this study. [ Time Frame: 2 months prior to study entry ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	900
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Case Group

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Potential cases of acute NAION will be prospectively identified by approximately 125 ophthalmology centers in the US and Europe. Patients must have presented to an ophthalmologist within 3 weeks of symptom onset.

Criteria

Inclusion Criteria:

Male aged ≥45 years;
Experienced abrupt visual change in only 1 eye

Exclusion Criteria:

Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
History of NAION or optic neuritis.
Participation in other studies within 60 days prior to entry in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759174

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 117 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481259
Study First Received:	September 22, 2008
Last Updated:	January 29, 2010
ClinicalTrials.gov Identifier:	NCT00759174 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Optic Neuropathy Acute NAION PDE5 Inhibitor

Additional relevant MeSH terms:

Eye Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

Optic Nerve Diseases
Cranial Nerve Diseases
Optic Neuropathy, Ischemic

ClinicalTrials.gov processed this record on February 08, 2010