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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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00759174
First received: September 22, 2008
Last updated: November 5, 2012
Last verified: November 2012
History of Changes

September 22, 2008
November 5, 2012
November 2008
October 2012   (final data collection date for primary outcome measure)
Acute NAION is the sole endpoint of interest in this study. [ Time Frame: 2 months prior to study entry ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00759174 on ClinicalTrials.gov Archive Site
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A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

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.

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.
Observational
Observational Model: Case-Crossover
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample

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.
Optic Neuropathy, Ischemic
Drug: No intervention
No intervention occurs in this observational study.
Case Group
Intervention: Drug: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
674
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Male
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT00759174
A1481259
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP