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

Phase 4

Terminated

• Conditions: Anterior Ischemic Optic Neuropathy
• Interventions: Drug: Diagnostic procedures

• Registration Number: NCT00867815
• Lead Sponsor: Bayer

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Study Start: 2009-07-13
• Primary Completion: 2017-12-29
• Study Completion: 2018-03-28
• Results First Submitted: 2018-12-26
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-21
• Last Update Submitted: 2019-01-21
• Results First Posted: 2019-01-23
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 10

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Diagnostic procedures	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)	Up to 45 days prior to study enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1	Day 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.
Number of Participants With Any Adverse Events Reported at Visit 2	From informed consent signed up to Visit 2 (Day 90+/-30)	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.

Trial Locations

Locations (12)

Retinal and Ophthalmic Consultants; 🇺🇸 Houston, Texas, United States

Palm Beach Eye Center; 🇺🇸 Atlantis, Florida, United States

National Ophthalmic Research Institute; 🇺🇸 Fort Myers, Florida, United States

Greider Eye Associates; 🇺🇸 Vista, California, United States

West Coast Eye Care; 🇺🇸 Fort Myers, Florida, United States

Sarasota Retina Institute; 🇺🇸 Sarasota, Florida, United States

Midwest Eye Institute; 🇨🇦 Toronto, Ontario, Canada

Office of Dr. Avrom Epstein, MD; 🇺🇸 Columbus, Ohio, United States

Asheville Eye Associates; 🇺🇸 Asheville, North Carolina, United States

Tulsa Clinical Research, LLC; 🇺🇸 Tulsa, Oklahoma, United States

Save Sight Institute; 🇦🇺 Sydney, New South Wales, Australia

Spoor and Associates; 🇺🇸 Warren, Michigan, United States