Clinical trial NCT00759174: A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
Official title: Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Neuropathy, Ischemic
Keywords: Optic Neuropathy Acute NAION PDE5 Inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 673
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases
timeFrame: 30-day period prior to onset of NAION symptoms
Secondary outcomes:
Other outcomes:
measure: 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
timeFrame: 30-day period prior to onset of NAION symptoms
measure: Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases
timeFrame: 60-day period prior to onset of NAION symptoms
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Anchorage
country: United States
facility: Pfizer Investigational Site
state: Alaska
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Loma Linda
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Southbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Bradenton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Lisle
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Prairie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Ruston
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Beverly
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Reno
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Manchester
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Chester
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Newark
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Roseland
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Teaneck
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Latham
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Troy
country: United States
facility: Pfizer Investigational Site
state: New York
city: Woodbury
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Lancaster
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Angers
country: France
facility: Pfizer Investigational Site
state: Cedex 09
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Dijon Cedex
country: France
facility: Pfizer Investigational Site
city: Grenoble
country: France
facility: Pfizer Investigational Site
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 19
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Strasbourg Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt am Main
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Ludwigshafen
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Munchen
country: Germany
facility: Pfizer Investigational Site
city: Münster
country: Germany
facility: Pfizer Investigational Site
city: Tübingen
country: Germany
facility: Pfizer Investigational Site
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Messina
country: Italy
facility: Pfizer Investigational Site
city: Parma
country: Italy
facility: Pfizer Investigational Site
city: Rome
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Alcala de Henares
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cosalada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Torrevieja
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Scarborough
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.