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

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

• Diagnostic procedures (Drug): 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

Primary outcomes

• 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 outcomes

• 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.

Sex: Male, ages: 40 Years to any

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

Participant flow

Outcome results

• Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) (Primary), Count of participants, Participants: PDE5 Inhibitor Use & Risk of NAION 10
• Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1 (Secondary), Count of participants, Participants: PDE5 Inhibitor Use & Risk of NAION 7
• Number of Participants With Any Adverse Events Reported at Visit 2 (Secondary), Count of participants, Participants: PDE5 Inhibitor Use & Risk of NAION 3

Adverse events

Time frame: From inform consent signed up to approximately 3 months after first diagnosis of NAION

Serious adverse events by term

Other adverse events by term

Limitations and caveats: Study was prematurely terminated, hence no statistical analysis was performed due to small sample of population.

• Study Protocol (PDF, 2016-03-02)
• Statistical Analysis Plan (PDF, 2018-03-20)

• Bayer Study Director, Study director, Bayer