stop_circleTerminated/Withdrawn

Anterior Ischemic Optic Neuropathy

Bayer Identifier:

12912

ClinicalTrials.gov Identifier:

NCT00867815

EudraCT Number:

2010-023586-22

EU CT Number:

Not Available
PDE5 inhibitor use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Trial purpose

The primary objective of this study is to determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.

Key Participants Requirements

Sex

Male

Age

40 - N/A
  • - NAION onset within 45 days before entry to the study
    - NAION onset definable by the subject within a 2 calendar day window
    - Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year prior to enrollment in the study
    - Age 40 years or older
  • - History of multiple sclerosis or optic neuritis
    - Evidence of temporal arteritis
    - History of vasculitis or collagen vascular disease
    - Previous history of NAION

Trial summary

Enrollment Goal
10
Trial Dates
July 2009 - March 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Myers Wyse Center For The EyeSkokie, 60076, United States
Withdrawn
Sacco Eye GroupVestal, 13850, United States
Withdrawn
Retinal and Ophthalmic ConsultantsNorthfield, 08225, United States
Terminated
Midwest Eye InstituteIndianapolis, 46290, United States
Withdrawn
St. Mary’s Health CareGrand Rapids, 49503, United States
Withdrawn
Georgia Eye Institute of the SoutheastSavannah, 31404, United States
Withdrawn
Eye Institute of West FloridaLargo, 33770, United States
Completed
Sarasota Retina InstituteSarasota, 34239, United States
Withdrawn
The Balance Disorders ClinicTallahassee, 32308, United States
Withdrawn
Apple Med-Research, Inc.Miami, 33155-1758, United States
Withdrawn
Premier Clinical ResearchSpokane, 99204, United States
Terminated
Spoor and AssociatesWarren, 48088, United States
Withdrawn
Southern California College of OptometryFullerton, 92831, United States
Completed
West Coast Eye CareFort Myers, 33908, United States
Withdrawn
St. Helena HospitalSt. Helena, 94574, United States
Completed
Retinal and Ophthalmic ConsultantsHouston, 77030, United States
Withdrawn
Medical and Surgical Eye SiteBrooklyn, 11219, United States
Withdrawn
Asheville Eye AssociatesHouston, 77025, United States
Withdrawn
Mid Florida Eye CenterMount Dora, 32757, United States
Withdrawn
Mayo Clinic - JacksonvilleJacksonville, 32224, United States
Withdrawn
Eye Centers of FloridaFort Myers, 33901, United States
Completed
Palm Beach Eye CenterAtlantis, 33461, United States
Withdrawn
Atlantic Institute of Clinical ResearchDaytona Beach, 32114, United States
Withdrawn
Logan Ophthalmic Research, LLDTamarac, 33321, United States
Withdrawn
Discovery Clinical TrialsSugar Land, 77478, United States
Withdrawn
Allen County Retinal SurgeonsFort Wayne, 46804, United States
Withdrawn
Kentuckiana Institute for Eye ResearchLouisville, 40207, United States
Withdrawn
John-Kenyon American Eye InstituteNew Albany, 47150, United States
Terminated
Asheville Eye AssociatesAsheville, 28803, United States
Completed
Office of Dr. Avrom Epstein, MDColumbus, 43215-7312, United States
Withdrawn
Columbia University Medical CenterNew York, 10032, United States
Withdrawn
Cornerstone Eye CareHigh Point, 27262, United States
Withdrawn
The Eye Associates of Manatee, LLPBradenton, 34209, United States
Withdrawn
The Eye Institiute for Medicine & SurgeryMelbourne, 32904, United States
Withdrawn
HOPE Research Institute, LLCPhoenix, 85032, United States
Withdrawn
Palm Beach Research CenterWest Palm Beach, 33409, United States
Withdrawn
Lugene Eye InstituteGlendale, 91205, United States
Withdrawn
Advanced Research Institute, Inc.Trinity, 34655, United States
Withdrawn
Center for Retina and Macular DiseaseWinter Haven, 33880, United States
Withdrawn
Office of Dr. Bruce Gilbert, MDGreat Neck, 11021, United States
Withdrawn
McGill UniversityMontreal, H3G 1A4, Canada
Completed
Midwest Eye InstituteToronto, M5G 1X5, Canada
Withdrawn
University of Ottawa Eye InstituteOttawa, K1H 8L6, Canada
Withdrawn
Retinal Consultants of ArizonaMesa, 85210, United States
Withdrawn
Retina Consultants, PAFort Worth, 76104, United States
Withdrawn
Eye Medical Center of FresnoFresno, 93720, United States
Withdrawn
Fletcher Allen Health CareBurlington, 05401, United States
Completed
National Ophthalmic Research InstituteFort Myers, 33912, United States
Withdrawn
Royal Alexandra HospitalEdmonton, T5H 3V9, Canada
Withdrawn
San Diego Clinical TrialsSan Diego, 92120, United States
Withdrawn
Magruder Eye InstituteOrlando, 32803, United States
Withdrawn
Carolina Research Center, Inc.Shelby, 28150, United States
Withdrawn
Florida Ophthalmic InstituteGainesville, 32605, United States
Withdrawn
PharmaCare Research, Inc.Miami, 33144, United States
Withdrawn
Charlotte Eye, Ear, Nose, & Throat Associates, PACharlotte, 28210, United States
Withdrawn
Retina Associates of South Texas, PASan Antonio, 78240, United States
Withdrawn
Klinikum DarmstadtDarmstadt, 64297, Germany
Withdrawn
Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen, 67063, Germany
Withdrawn
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Withdrawn
Universitätsklinikum RegensburgRegensburg, 93053, Germany
Withdrawn
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Withdrawn
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Terminated
Greider Eye AssociatesVista, 92083, United States
Completed
Tulsa Clinical Research, LLCTulsa, 74014, United States
Withdrawn
Univ. of California San Diego - La JollaLa Jolla, 92093, United States
Withdrawn
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Withdrawn
VISION SAKent Town, 5067, Australia
Completed
Save Sight InstituteSydney, 2000, Australia
Withdrawn
Annandale Eye CareAnnandale, 2038, Australia
Withdrawn
Vision Eye InstituteChatswood, 2067, Australia
Withdrawn
A.O.U. CareggiFirenze, 50134, Italy
Withdrawn
Katzen Eye GroupLutherville, 21093, United States
Withdrawn
Therafirst Medical CenterFt. Lauderdale, 33308, United States
Withdrawn
Hospital Universitario "José Eleuterio González"Monterrey, 64460, Mexico
Withdrawn
Servicios Hospitalarios de México, S.A. de CV.Chihuahua, 31238, Mexico
Withdrawn
Alta Pharmaceutical Research Center, LLCDunwoody, 30338, United States
Withdrawn
Global Research AssociatesStockbridge, 30281, United States

Primary Outcome

  • Confirmed diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION).
    date_rangeTime Frame:
    Up to 45 days prior to study enrollment
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Any additional safety information provided by the subject.
    date_rangeTime Frame:
    From Baseline to Visit 2 (Day 90+/-30)
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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