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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ischemic Optic Neuropathy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male aged ≥45 years;

- Experienced abrupt visual change in only 1 eye

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00759174
Pfizer
Completed
A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

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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
Not Provided
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
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
673
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.
Sexes Eligible for Study: Male
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT00759174
A1481259
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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