NCT01131104

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 345 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Nonarteritic Anterior Ischemic Optic Neuropathy

Interventions

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

Timeline

• Start date: 2010-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2010-05-26
• Last updated: 2018-04-05
• Results posted: 2018-04-05

Locations

44 sites across 1 country: United States