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

NCT00759174 | Completed Results

• 1 other identifier: A1481259
• Study Type: observational
• Target: 673
• Locations: 6 countries
• Sites: 105

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.

Conditions

Optic Neuropathy, Ischemic

Keywords

Optic Neuropathy Acute NAION PDE5 Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• 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

  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

  60-day period prior to onset of NAION symptoms

Study Arms (1)

Case Group

Drug: No intervention

Interventions

No intervention DRUG

No intervention occurs in this observational study.

Case Group

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male aged ≥45 years;
• Experienced abrupt visual change in only 1 eye

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (105)

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

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Mobile, Alabama, 36606, United States

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Anchorage, Alaska, 99501, United States

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Little Rock, Arkansas, 72205-7199, United States

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Little Rock, Arkansas, 72212, United States

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Loma Linda, California, 92354, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90095, United States

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Oceanside, California, 92056, United States

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Pasadena, California, 91105, United States

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Aurora, Colorado, 80045, United States

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New Haven, Connecticut, 06510, United States

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Southbury, Connecticut, 06488, United States

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Waterbury, Connecticut, 06708, United States

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Washington D.C., District of Columbia, 20007, United States

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Washington D.C., District of Columbia, 20037, United States

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Bradenton, Florida, 34208, United States

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Miami, Florida, 33136, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30909, United States

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Lisle, Illinois, 60532, United States

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Dubuque, Iowa, 52002, United States

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Prairie Village, Kansas, 66208, United States

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Lafayette, Louisiana, 70503, United States

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Lafayette, Louisiana, 70506, United States

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Ruston, Louisiana, 71270, United States

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Baltimore, Maryland, 21204, United States

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Baltimore, Maryland, 21287, United States

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Beverly, Massachusetts, 01915, United States

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Boston, Massachusetts, 02114, United States

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North Dartmouth, Massachusetts, 02747, United States

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Ann Arbor, Michigan, 48105, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55455, United States

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St Louis, Missouri, 63104, United States

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Omaha, Nebraska, 68198, United States

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Reno, Nevada, 89502, United States

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Lebanon, New Hampshire, 03756, United States

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Manchester, New Hampshire, 03104, United States

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Chester, New Jersey, 07930, United States

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Newark, New Jersey, 07103, United States

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Roseland, New Jersey, 07068, United States

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Teaneck, New Jersey, 07666, United States

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Latham, New York, 12110, United States

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Rochester, New York, 14642, United States

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Stony Brook, New York, 11794, United States

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Troy, New York, 12180, United States

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Woodbury, New York, 11788, United States

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Durham, North Carolina, 27705, United States

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Cincinnati, Ohio, 45242, United States

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Columbus, Ohio, 43215, United States

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Portland, Oregon, 97239, United States

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Lancaster, Pennsylvania, 17602, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Charleston, South Carolina, 29425, United States

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Greenville, South Carolina, 29615, United States

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Spartanburg, South Carolina, 29302, United States

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Spartanburg, South Carolina, 29306, United States

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Austin, Texas, 78705, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84132, United States

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Richmond, Virginia, 23226, United States

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Richmond, Virginia, 23298, United States

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Seattle, Washington, 98104, United States

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Angers, Cedex 09, 49933, France

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Amiens, 80000, France

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Dijon, 21033, France

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Grenoble, 38043, France

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Nantes, 44000, France

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Paris, 75012, France

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Paris, 75940, France

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Strasbourg, 67091, France

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Berlin, 13353, Germany

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Frankfurt am Main, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, Germany

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Karlsruhe, 76133, Germany

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Ludwigshafen, 67063, Germany

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Mainz, 55131, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Bari, 70124, Italy

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Bologna, 40138, Italy

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Florence, 50134, Italy

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Messina, 98124, Italy

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Parma, 43100, Italy

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Rome, 00133, Italy

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Torino, 10122, Italy

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Alcalá de Henares, Madrid, 28805, Spain

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Barcelona, 08206, Spain

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Barcelona, 08907, Spain

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Cosalada, 28822, Spain

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Madrid, 28010, Spain

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Madrid, 28034, Spain

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Torrevieja, 03186, Spain

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Valencia, 46009, Spain

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Liverpool, L7 8XP, United Kingdom

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Manchester, M13 9WH, United Kingdom

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Scarborough, YO12 6QL, United Kingdom

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Related Publications (1)

• Campbell UB, Walker AM, Gaffney M, Petronis KR, Creanga D, Quinn S, Klein BE, Laties AM, Lewis M, Sharlip ID, Kolitsopoulos F, Klee BJ, Mo J, Reynolds RF. Acute nonarteritic anterior ischemic optic neuropathy and exposure to phosphodiesterase type 5 inhibitors. J Sex Med. 2015 Jan;12(1):139-51. doi: 10.1111/jsm.12726. Epub 2014 Oct 31.

  PMID: 25358826 DERIVED

Related Links

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

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Potential for bias from inaccuracies in recall of exposure and exposure-based enrollment were evaluated. Although these sources of bias cannot be excluded, they were unlikely to have substantially affected the primary results.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 25, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 1, 2021
• Results First Posted: October 17, 2013

Record last verified: 2021-01

Locations

GB (3); FR (8); DE (10); IT (7); ES (8); US (69)