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

Completed

• Conditions: Optic Neuropathy, Ischemic
• Interventions: Drug: No intervention

• Registration Number: NCT00759174
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.

Detailed Description

Sites will identify patients who meet the entry criteria during the conduct of their normal practice. Patients meeting these criteria will be offered participation in the study after reading and completing an informed consent document.

Study Timeline

• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-25
• Study Start: 2008-11
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-08-08
• Results First Submitted QC: 2013-08-08
• Results First Posted: 2013-10-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 673

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	No intervention	-

Primary Outcome Measures

Name	Time	Method
Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases	30-day period prior to onset of NAION symptoms	Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Scarborough, United Kingdom