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

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

Official Title
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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)

Conditions
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Anterior Ischemic Optic Neuropathy

Intervention / Treatment
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* Drug: Diagnostic procedures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Drug: Diagnostic procedures<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.