A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00759174
• Date of registration: 22/09/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
• Scientific title: Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION
• Date of first enrolment: November 2008
• Target sample size: 673
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00759174
• Study type: Observational

Countries of recruitment

France, Germany, Italy, Spain, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male aged =45 years;

- Experienced abrupt visual change in only 1 eye

Exclusion Criteria:

- Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic
process or optic neuritis;

- History of NAION or optic neuritis.

- Participation in other studies within 60 days prior to entry in the study.



Age minimum: 45 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Optic Neuropathy, Ischemic

Intervention(s)

Drug: No intervention

Primary Outcome(s)

Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases [Time Frame: 30-day period prior to onset of NAION symptoms]

Secondary ID(s)

A1481259

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/10/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00759174