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

Bayer

Status and phase: Terminated; Phase 4

Conditions: Anterior Ischemic Optic Neuropathy

Treatments: Drug: Diagnostic procedures

Study type: Interventional

Funder types: Industry

Identifiers

NCT00867815

2010-023586-22 (EudraCT Number)

12912

Details and patient eligibility

About

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.

Full description

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

Enrollment: 10 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Arm 1

Other group

Treatment:

Drug: Diagnostic procedures