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

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NCT00759174

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Optic Neuropathy, Ischemic
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.

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Optic Neuropathy, IschemicA Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
NCT00759174
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. Anchorage, Alaska
  4. Little Rock, Arkansas
  5. Little Rock, Arkansas
  6. Loma Linda, California
  7. Long Beach, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Oceanside, California
  11. Pasadena, California
  12. Aurora, Colorado
  13. New Haven, Connecticut
  14. Southbury, Connecticut
  15. Waterbury, Connecticut
  16. Washington, District of Columbia
  17. Washington, District of Columbia
  18. Bradenton, Florida
  19. Miami, Florida
  20. Tampa, Florida
  21. Atlanta, Georgia
  22. Augusta, Georgia
  23. Lisle, Illinois
  24. Dubuque, Iowa
  25. Prairie Village, Kansas
  26. Lafayette, Louisiana
  27. Lafayette, Louisiana
  28. Ruston, Louisiana
  29. Baltimore, Maryland
  30. Baltimore, Maryland
  31. Beverly, Massachusetts
  32. Boston, Massachusetts
  33. North Dartmouth, Massachusetts
  34. Ann Arbor, Michigan
  35. Detroit, Michigan
  36. Minneapolis, Minnesota
  37. St. Louis, Missouri
  38. Omaha, Nebraska
  39. Reno, Nevada
  40. Lebanon, New Hampshire
  41. Manchester, New Hampshire
  42. Chester, New Jersey
  43. Newark, New Jersey
  44. Roseland, New Jersey
  45. Teaneck, New Jersey
  46. Latham, New York
  47. Rochester, New York
  48. Stony Brook, New York
  49. Troy, New York
  50. Woodbury, New York
  51. Durham, North Carolina
  52. Cincinnati, Ohio
  53. Columbus, Ohio
  54. Portland, Oregon
  55. Lancaster, Pennsylvania
  56. Philadelphia, Pennsylvania
  57. Philadelphia, Pennsylvania
  58. Philadelphia, Pennsylvania
  59. Pittsburgh, Pennsylvania
  60. Charleston, South Carolina
  61. Greenville, South Carolina
  62. Spartanburg, South Carolina
  63. Spartanburg, South Carolina
  64. Austin, Texas
  65. Houston, Texas
  66. Salt Lake City, Utah
  67. Richmond, Virginia
  68. Richmond, Virginia
  69. Seattle, Washington
  70. Angers, Cedex 09
  71. Amiens,
  72. Dijon Cedex,
  73. Grenoble,
  74. Nantes,
  75. Paris Cedex 19,
  76. Paris,
  77. Strasbourg Cedex,
  78. Berlin,
  79. Frankfurt am Main,
  80. Freiburg,
  81. Hamburg,
  82. Karlsruhe,
  83. Ludwigshafen,
  84. Mainz,
  85. Munchen,
  86. Münster,
  87. Tübingen,
  88. Bari,
  89. Bologna,
  90. Firenze,
  91. Messina,
  92. Parma,
  93. Rome,
  94. Torino,
  95. Alcala de Henares, Madrid
  96. Barcelona,
  97. Barcelona,
  98. Cosalada,
  99. Madrid,
  100. Madrid,
  101. Torrevieja,
  102. Valencia,
  103. Liverpool,
  104. Manchester,
  105. Scarborough,
Male
45 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Optic Neuropathy, Ischemic
Intervention Drug: No intervention
No intervention occurs in this observational study.
Study Groups/Cohorts Case Group
Intervention: Drug: No intervention
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2013)		673
Original Estimated Enrollment
 (submitted: September 22, 2008)		900
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:Male
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00759174
Other Study ID Numbers A1481259
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2013