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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
  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 Phase
Optic Neuropathy, Ischemic
 Drug: No intervention
 Phase 4

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Acute NAION is the sole endpoint of interest in this study. [ Time Frame: 2 months prior to study entry ] [ Designated as safety issue: Yes ]

Enrollment: 674
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
Genders 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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00759174     History of Changes
Other Study ID Numbers: A1481259
Study First Received: September 22, 2008
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013