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Completed

NCT Number: NCT01131104

A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors

Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.

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Key information

Conditions

Nonarteritic Anterior Ischemic Optic Neuropathy Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases Optic Neuropathy, Ischemic Vascular Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Alabama Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male subjects, at least 18 years of age, who are willing to participate in the study
  • Participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of NAION symptoms to an ophthalmologist that resulted in a diagnosis of Suspected NAION by the investigator

Exclusion criteria

  • Previous history of NAION
  • Previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis
  • History of glaucoma in either one or both eyes
  • History of multiple sclerosis or diagnostic testing evidence of optic neuritis
  • Have dementia or other reasons for memory impairment in the opinion of the investigator
  • Have participated in other non-observational studies within 3 months of NAION onset

Treatment and study plan

PDE5 Inhibitors

Drug

Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.

Other names: tadalafil, sildenafil, vardenafil

Primary outcomes

  1. 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use

    Time frame: 30 days prior to NAION onset

    Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Prospective Case-crossover Study to Evaluate the Possible Association Between the Use of PDE5 Inhibitors and the Risk of Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 26, 2010
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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