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A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00759174
First received: September 22, 2008
Last updated: August 8, 2013
Last verified: August 2013
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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 |
Resource links provided by NLM:
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 ]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 ]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.
| 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 (Adult, Senior) |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00759174
Show 105 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759174
Show 105 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017