A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
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ClinicalTrials.gov Identifier: NCT00759174 |
Recruitment Status :
Completed
First Posted : September 25, 2008
Results First Posted : October 17, 2013
Last Update Posted : February 1, 2021
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Condition or disease | Intervention/treatment |
---|---|
Optic Neuropathy, Ischemic | Drug: No intervention |
Study Type : | Observational |
Actual Enrollment : | 673 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Retrospective |
Official Title: | Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |

Group/Cohort | Intervention/treatment |
---|---|
Case Group |
Drug: No intervention
No intervention occurs in this observational study. |
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759174

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
ClinicalTrials.gov Identifier: | NCT00759174 |
Other Study ID Numbers: |
A1481259 |
First Posted: | September 25, 2008 Key Record Dates |
Results First Posted: | October 17, 2013 |
Last Update Posted: | February 1, 2021 |
Last Verified: | January 2021 |
Optic Neuropathy Acute NAION PDE5 Inhibitor |
Optic Nerve Diseases Optic Neuropathy, Ischemic Cranial Nerve Diseases Nervous System Diseases |
Eye Diseases Vascular Diseases Cardiovascular Diseases |