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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

673

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • Pfizer Investigational Site
      • Dijon Cedex, France, 21033
        • Pfizer Investigational Site
      • Grenoble, France, 38043
        • Pfizer Investigational Site
      • Nantes, France, 44000
        • Pfizer Investigational Site
      • Paris, France, 75012
        • Pfizer Investigational Site
      • Paris Cedex 19, France, 75940
        • Pfizer Investigational Site
      • Strasbourg Cedex, France, 67091
        • Pfizer Investigational Site
    • Cedex 09
      • Angers, Cedex 09, France, 49933
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Pfizer Investigational Site
      • Frankfurt am Main, Germany, 60590
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Hamburg, Germany
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76133
        • Pfizer Investigational Site
      • Ludwigshafen, Germany, 67063
        • Pfizer Investigational Site
      • Mainz, Germany, 55131
        • Pfizer Investigational Site
      • Munchen, Germany, 81675
        • Pfizer Investigational Site
      • Münster, Germany, 48149
        • Pfizer Investigational Site
      • Tübingen, Germany, 72076
        • Pfizer Investigational Site
  • Italy
      • Bari, Italy, 70124
        • Pfizer Investigational Site
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Firenze, Italy, 50134
        • Pfizer Investigational Site
      • Messina, Italy, 98124
        • Pfizer Investigational Site
      • Parma, Italy, 43100
        • Pfizer Investigational Site
      • Rome, Italy, 00133
        • Pfizer Investigational Site
      • Torino, Italy, 10122
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08907
        • Pfizer Investigational Site
      • Barcelona, Spain, 08206
        • Pfizer Investigational Site
      • Cosalada, Spain, 28822
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28010
        • Pfizer Investigational Site
      • Torrevieja, Spain, 03186
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Pfizer Investigational Site
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M13 9WH
        • Pfizer Investigational Site
      • Scarborough, United Kingdom, YO12 6QL
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36606
        • Pfizer Investigational Site
    • Alaska
      • Anchorage, Alaska, United States, 99501
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-7199
        • Pfizer Investigational Site
      • Little Rock, Arkansas, United States, 72212
        • Pfizer Investigational Site
    • California
      • Loma Linda, California, United States, 92354
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90813
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Oceanside, California, United States, 92056
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91105
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Pfizer Investigational Site
      • Southbury, Connecticut, United States, 06488
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20007
        • Pfizer Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34208
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33612
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, United States, 30909
        • Pfizer Investigational Site
    • Illinois
      • Lisle, Illinois, United States, 60532
        • Pfizer Investigational Site
    • Iowa
      • Dubuque, Iowa, United States, 52002
        • Pfizer Investigational Site
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Pfizer Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Pfizer Investigational Site
      • Lafayette, Louisiana, United States, 70506
        • Pfizer Investigational Site
      • Ruston, Louisiana, United States, 71270
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Pfizer Investigational Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
      • Manchester, New Hampshire, United States, 03104
        • Pfizer Investigational Site
    • New Jersey
      • Chester, New Jersey, United States, 07930
        • Pfizer Investigational Site
      • Newark, New Jersey, United States, 07103
        • Pfizer Investigational Site
      • Roseland, New Jersey, United States, 07068
        • Pfizer Investigational Site
      • Teaneck, New Jersey, United States, 07666
        • Pfizer Investigational Site
    • New York
      • Latham, New York, United States, 12110
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
      • Stony Brook, New York, United States, 11794
        • Pfizer Investigational Site
      • Troy, New York, United States, 12180
        • Pfizer Investigational Site
      • Woodbury, New York, United States, 11788
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43215
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
      • Greenville, South Carolina, United States, 29615
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States, 29302
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States, 29306
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23226
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Potential cases of acute NAION will be prospectively identified by approximately 125 ophthalmology centers in the US and Europe. Patients must have presented to an ophthalmologist within 3 weeks of symptom onset.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case Group
Drug: No intervention
No intervention occurs in this observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
30-day period prior to onset of NAION symptoms
Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases
Time Frame: 60-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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 22, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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