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

Phase 4TerminatedNCT00867815

Bayer10 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Anterior Ischemic Optic Neuropathy

Interventions

Diagnostic proceduresDRUG

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

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (13)

Greider Eye Associates

Vista, California, United States

Palm Beach Eye Center

Atlantis, Florida, United States

West Coast Eye Care

Fort Myers, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 45 days prior to study enrollment

Secondary Outcomes

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.

Time frame: 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.

Time frame: From informed consent signed up to Visit 2 (Day 90+/-30)

Data from ClinicalTrials.gov

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