Clinical trial NCT00867815: PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Official title: Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anterior Ischemic Optic Neuropathy
Keywords: Non-arteritic Anterior Ischemic Optic Neuropathy
NAION
PDE5 inhibitors
vardenafil
Levitra
sildenafil
Viagra
Tadalafil
Cialis
acute vision loss
vision loss
blurred vision
optic neuropathy
erectile dysfunction.
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-03-24
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this study is to determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.

Detailed description: Collected data will be compared to historic data of the same participant in case-crossover design.

Eligibility criteria: Inclusion Criteria:

* NAION onset within 45 days before entry to the study
* NAION onset definable by the subject within a 2 calendar day window
* Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year prior to enrollment in the study
* Age 40 years or older

Exclusion Criteria:

* History of multiple sclerosis or optic neuritis
* Evidence of temporal arteritis
* History of vasculitis or collagen vascular disease
* Previous history of NAION

Primary outcomes:
measure: Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
timeFrame: Up to 45 days prior to study enrollment
Secondary outcomes:
measure: Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1
timeFrame: Day 1
measure: Number of Participants With Any Adverse Events Reported at Visit 2
timeFrame: From informed consent signed up to Visit 2 (Day 90+/-30)
Other outcomes:
Locations:
city: Vista
country: United States
facility: Greider Eye Associates
state: California
city: Atlantis
country: United States
facility: Palm Beach Eye Center
state: Florida
city: Fort Myers
country: United States
facility: West Coast Eye Care
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Warren
country: United States
facility: Spoor and Associates
state: Michigan
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Columbus
country: United States
facility: Office of Dr. Avrom Epstein, MD
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Clinical Research, LLC
state: Oklahoma
city: Houston
country: United States
facility: Retinal and Ophthalmic Consultants
state: Texas
city: Sydney
country: Australia
facility: Save Sight Institute
state: New South Wales
city: Toronto
country: Canada
facility: Midwest Eye Institute
state: Ontario
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: