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

Optic Neuropathy, Ischemic Clinical Trial

Official title:

Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759174
• Other study ID #: A1481259
• Status: Completed
• Start date: November 2008
• Est. completion date: October 2012

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 673
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Drug:
• No intervention
No intervention occurs in this observational study.

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Amiens
France	Pfizer Investigational Site	Angers	Cedex 09
France	Pfizer Investigational Site	Dijon Cedex
France	Pfizer Investigational Site	Grenoble
France	Pfizer Investigational Site	Nantes
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris Cedex 19
France	Pfizer Investigational Site	Strasbourg Cedex
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Frankfurt am Main
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Ludwigshafen
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Munchen
Germany	Pfizer Investigational Site	Münster
Germany	Pfizer Investigational Site	Tübingen
Italy	Pfizer Investigational Site	Bari
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Messina
Italy	Pfizer Investigational Site	Parma
Italy	Pfizer Investigational Site	Rome
Italy	Pfizer Investigational Site	Torino
Spain	Pfizer Investigational Site	Alcala de Henares	Madrid
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Cosalada
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Torrevieja
Spain	Pfizer Investigational Site	Valencia
United Kingdom	Pfizer Investigational Site	Liverpool
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Scarborough
United States	Pfizer Investigational Site	Anchorage	Alaska
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Augusta	Georgia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Beverly	Massachusetts
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Bradenton	Florida
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Chester	New Jersey
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Dubuque	Iowa
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Lafayette	Louisiana
United States	Pfizer Investigational Site	Lafayette	Louisiana
United States	Pfizer Investigational Site	Lancaster	Pennsylvania
United States	Pfizer Investigational Site	Latham	New York
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Lisle	Illinois
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Loma Linda	California
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Manchester	New Hampshire
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	Newark	New Jersey
United States	Pfizer Investigational Site	North Dartmouth	Massachusetts
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Prairie Village	Kansas
United States	Pfizer Investigational Site	Reno	Nevada
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Roseland	New Jersey
United States	Pfizer Investigational Site	Ruston	Louisiana
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Southbury	Connecticut
United States	Pfizer Investigational Site	Spartanburg	South Carolina
United States	Pfizer Investigational Site	Spartanburg	South Carolina
United States	Pfizer Investigational Site	Stony Brook	New York
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Teaneck	New Jersey
United States	Pfizer Investigational Site	Troy	New York
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	Woodbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases	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.	30-day period prior to onset of NAION symptoms
Other	Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases	Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows.	60-day period prior to onset of NAION symptoms
Primary	Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases	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.	30-day period prior to onset of NAION symptoms

External Links

•   To obtain contact information for a study center near you, click here.