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

Condition(s) targeted: Optic Neuropathy, Ischemic

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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

Study design: Case-Crossover, Retrospective

Primary outcome: Acute NAION is the sole endpoint of interest in this 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.

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Dijon Cedex 21033, France; Recruiting

Pfizer Investigational Site, Paris Cedex 19 75940, France; Recruiting

Pfizer Investigational Site, Paris 75012, France; Recruiting

Pfizer Investigational Site, Freiburg 79106, Germany; Recruiting

Pfizer Investigational Site, Mainz 55131, Germany; Recruiting

Pfizer Investigational Site, Regensburg 93059, Germany; Recruiting

Pfizer Investigational Site, Tübingen 72076, Germany; Recruiting

Pfizer Investigational Site, Karlsruhe 76133, Germany; Recruiting

Pfizer Investigational Site, Duisburg 47249, Germany; Recruiting

Pfizer Investigational Site, Essen 45329, Germany; Recruiting

Pfizer Investigational Site, Kulmbach 95326, Germany; Recruiting

Pfizer Investigational Site, Berlin 13353, Germany; Recruiting

Pfizer Investigational Site, Gummersbach 51643, Germany; Recruiting

Pfizer Investigational Site, Weilheim 82362, Germany; Recruiting

Pfizer Investigational Site, Troisdorf 53844, Germany; Recruiting

Pfizer Investigational Site, Münster 48149, Germany; Recruiting

Pfizer Investigational Site, Essen 45122, Germany; Recruiting

Pfizer Investigational Site, Bonn 53115, Germany; Recruiting

Pfizer Investigational Site, Frankfurt am Main 60590, Germany; Recruiting

Pfizer Investigational Site, Firenze 50134, Italy; Recruiting

Pfizer Investigational Site, Pisa 56126, Italy; Recruiting

Pfizer Investigational Site, Bologna 40138, Italy; Recruiting

Pfizer Investigational Site, Parma 43100, Italy; Recruiting

Pfizer Investigational Site, Milan 20142, Italy; Recruiting

Pfizer Investigational Site, Birmingham, Alabama 35294, United States; Recruiting

Pfizer Investigational Site, Mobile, Alabama 36606, United States; Recruiting

Pfizer Investigational Site, Anchorage, Alaska 99501, United States; Recruiting

Pfizer Investigational Site, Little Rock, Arkansas 72205-7199, United States; Recruiting

Pfizer Investigational Site, Little Rock, Arkansas 72212, United States; Recruiting

Pfizer Investigational Site, Los Angeles, California 90033, United States; Recruiting

Pfizer Investigational Site, Pasadena, California 91105, United States; Recruiting

Pfizer Investigational Site, Loma Linda, California 92354, United States; Recruiting

Pfizer Investigational Site, Los Angeles, California 90025, United States; Recruiting

Pfizer Investigational Site, Los Angeles, California 90095, United States; Recruiting

Pfizer Investigational Site, Oceanside, California 92056, United States; Recruiting

Pfizer Investigational Site, Long Beach, California 90813, United States; Recruiting

Pfizer Investigational Site, Los Altos, California 94024, United States; Recruiting

Pfizer Investigational Site, Aurora, Colorado 80045, United States; Not yet recruiting

Pfizer Investigational Site, Aurora, Colorado 80012, United States; Recruiting

Pfizer Investigational Site, New Haven, Connecticut 06510, United States; Recruiting

Pfizer Investigational Site, Southbury, Connecticut 06488, United States; Recruiting

Pfizer Investigational Site, Waterbury, Connecticut 06708, United States; Recruiting

Pfizer Investigational Site, Washington, District of Columbia 20007, United States; Recruiting

Pfizer Investigational Site, Washington, District of Columbia 20037, United States; Recruiting

Pfizer Investigational Site, Fort Myers, Florida 33901, United States; Recruiting

Pfizer Investigational Site, Tampa, Florida 33612, United States; Recruiting

Pfizer Investigational Site, Bradenton, Florida 34208, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33136, United States; Recruiting

Pfizer Investigational Site, Atlanta, Georgia 30322, United States; Recruiting

Pfizer Investigational Site, Chicago, Illinois 60637, United States; Recruiting

Pfizer Investigational Site, Lisle, Illinois 60532, United States; Recruiting

Pfizer Investigational Site, Prairie Village, Kansas 66208, United States; Recruiting

Pfizer Investigational Site, Baton Rouge, Louisiana 70810, United States; Recruiting

Pfizer Investigational Site, Baton Rouge, Louisiana 70807, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21287, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21204, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02114, United States; Recruiting

Pfizer Investigational Site, Beverly, Massachusetts 01915, United States; Recruiting

Pfizer Investigational Site, Ann Arbor, Michigan 48105, United States; Recruiting

Pfizer Investigational Site, Detroit, Michigan 48202, United States; Recruiting

Pfizer Investigational Site, Minneapolis, Minnesota 55455, United States; Recruiting

Pfizer Investigational Site, Minneapolis, Minnesota 55416, United States; Recruiting

Pfizer Investigational Site, Kansas City, Missouri 64154, United States; Recruiting

Pfizer Investigational Site, St. Louis, Missouri 63104, United States; Recruiting

Pfizer Investigational Site, Omaha, Nebraska 68198, United States; Recruiting

Pfizer Investigational Site, Lebanon, New Hampshire 03756, United States; Recruiting

Pfizer Investigational Site, Manchester, New Hampshire 03104, United States; Recruiting

Pfizer Investigational Site, Teaneck, New Jersey 07666, United States; Recruiting

Pfizer Investigational Site, New Brunswick, New Jersey 08901, United States; Recruiting

Pfizer Investigational Site, Rochester, New York 14642, United States; Recruiting

Pfizer Investigational Site, New York, New York 10021, United States; Recruiting

Pfizer Investigational Site, Stony Brook, New York 11794, United States; Recruiting

Pfizer Investigational Site, Woodbury, New York 11788, United States; Recruiting

Pfizer Investigational Site, Latham, New York 12110, United States; Recruiting

Pfizer Investigational Site, Charlotte, North Carolina 28210, United States; Recruiting

Pfizer Investigational Site, Durham, North Carolina 27705, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43215, United States; Recruiting

Pfizer Investigational Site, Cincinnati, Ohio 45242, United States; Recruiting

Pfizer Investigational Site, Portland, Oregon 97239, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19107, United States; Recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15212, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19114, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19104, United States; Recruiting

Pfizer Investigational Site, Lancaster, Pennsylvania 17602, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19102, United States; Recruiting

Pfizer Investigational Site, Charleston, South Carolina 29425, United States; Recruiting

Pfizer Investigational Site, Greenville, South Carolina 29615, United States; Recruiting

Pfizer Investigational Site, Austin, Texas 78705, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77030, United States; Recruiting

Pfizer Investigational Site, Salt Lake City, Utah 84132, United States; Recruiting

Pfizer Investigational Site, Richmond, Virginia 23298, United States; Recruiting

Pfizer Investigational Site, Richmond, Virginia 23226, United States; Recruiting

Pfizer Investigational Site, Seattle, Washington 98104, United States; Recruiting

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

Starting date: October 2008
Ending date: October 2011
Last updated: October 5, 2009