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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00759174
First received: September 22, 2008
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Optic Neuropathy, Ischemic
Drug: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 673
Study Start Date: November 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Case Group Drug: No intervention
No intervention occurs in this observational study.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759174

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Mobile, Alabama, United States, 36606
United States, Alaska
Pfizer Investigational Site
Anchorage, Alaska, United States, 99501
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205-7199
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72212
United States, California
Pfizer Investigational Site
Loma Linda, California, United States, 92354
Pfizer Investigational Site
Long Beach, California, United States, 90813
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Oceanside, California, United States, 92056
Pfizer Investigational Site
Pasadena, California, United States, 91105
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
Southbury, Connecticut, United States, 06488
Pfizer Investigational Site
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007
Pfizer Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
Pfizer Investigational Site
Bradenton, Florida, United States, 34208
Pfizer Investigational Site
Miami, Florida, United States, 33136
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
Pfizer Investigational Site
Augusta, Georgia, United States, 30909
United States, Illinois
Pfizer Investigational Site
Lisle, Illinois, United States, 60532
United States, Iowa
Pfizer Investigational Site
Dubuque, Iowa, United States, 52002
United States, Kansas
Pfizer Investigational Site
Prairie Village, Kansas, United States, 66208
United States, Louisiana
Pfizer Investigational Site
Lafayette, Louisiana, United States, 70503
Pfizer Investigational Site
Lafayette, Louisiana, United States, 70506
Pfizer Investigational Site
Ruston, Louisiana, United States, 71270
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21204
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Pfizer Investigational Site
Beverly, Massachusetts, United States, 01915
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48105
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63104
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68198
United States, Nevada
Pfizer Investigational Site
Reno, Nevada, United States, 89502
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03756
Pfizer Investigational Site
Manchester, New Hampshire, United States, 03104
United States, New Jersey
Pfizer Investigational Site
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
United States, New York
Pfizer Investigational Site
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
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27705
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
Pfizer Investigational Site
Columbus, Ohio, United States, 43215
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pfizer Investigational Site
Lancaster, Pennsylvania, United States, 17602
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Pfizer Investigational Site
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
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23226
Pfizer Investigational Site
Richmond, Virginia, United States, 23298
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
France
Pfizer Investigational Site
Angers, Cedex 09, France, 49933
Pfizer Investigational Site
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
Germany
Pfizer Investigational Site
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
Italy
Pfizer Investigational Site
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
Spain
Pfizer Investigational Site
Alcala de Henares, Madrid, Spain, 28805
Pfizer Investigational Site
Barcelona, Spain, 08206
Pfizer Investigational Site
Barcelona, Spain, 08907
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
United Kingdom
Pfizer Investigational Site
Liverpool, United Kingdom, L7 8XP
Pfizer Investigational Site
Manchester, United Kingdom, M13 9WH
Pfizer Investigational Site
Scarborough, United Kingdom, YO12 6QL
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00759174     History of Changes
Other Study ID Numbers: A1481259
Study First Received: September 22, 2008
Results First Received: August 8, 2013
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Optic Neuropathy Acute NAION PDE5 Inhibitor

Additional relevant MeSH terms:
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014