PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Anterior Ischemic Optic Neuropathy Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00867815
• Other study ID #: 12912
• Secondary ID: 2010-023586-22
• Status: Terminated
• Phase: Phase 4
• Start date: July 13, 2009
• Est. completion date: March 28, 2018

Study information

• Verified date: January 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 28, 2018
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Ischemic Optic Neuropathy
• Ischemia
• Optic Nerve Diseases
• Optic Neuritis
• Optic Neuropathy, Ischemic
• Peripheral Nervous System Diseases

Intervention

Drug:
• Diagnostic procedures
The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview

Locations

Country	Name	City	State
Australia	Save Sight Institute	Sydney	New South Wales
Canada	Midwest Eye Institute	Toronto	Ontario
United States	Asheville Eye Associates	Asheville	North Carolina
United States	Palm Beach Eye Center	Atlantis	Florida
United States	Office of Dr. Avrom Epstein, MD	Columbus	Ohio
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	West Coast Eye Care	Fort Myers	Florida
United States	Retinal and Ophthalmic Consultants	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	Greider Eye Associates	Vista	California
United States	Spoor and Associates	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)	The study population consisted of adult men, first diagnosed with NAION which started within 45 days before study start and took PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) in the 1 year prior to enrollment.	Up to 45 days prior to study enrollment
Secondary	Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1	The safety population includes participants who signed informed consent and who had any of the following collected at Visit 1 for safety: laboratory values, physical exam, any eye exams, or adverse events.	Day 1
Secondary	Number of Participants With Any Adverse Events Reported at Visit 2	An adverse event is any untoward medical occurrence in a subject or clinical investigation subject and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally occurring during the trial.	From informed consent signed up to Visit 2 (Day 90+/-30)

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