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

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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)

10 participants in 1 patient group

Arm 1
Other group
Treatment:
Drug: Diagnostic procedures

Trial documents
2

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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