PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

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)

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.

Study Overview

• Status: Terminated
• Conditions: Anterior Ischemic Optic Neuropathy
• Intervention / Treatment: Drug: Diagnostic procedures

Detailed Description

Collected data will be compared to historic data of the same participant in case-crossover design.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Save Sight Institute
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Midwest Eye Institute
• United States
  • California
    • Vista, California, United States, 92083
      • Greider Eye Associates
  • Florida
    • Atlantis, Florida, United States, 33461
      • Palm Beach Eye Center
    • Fort Myers, Florida, United States, 33912
      • National Ophthalmic Research Institute
    • Fort Myers, Florida, United States, 33908
      • West Coast Eye Care
    • Sarasota, Florida, United States, 34239
      • Sarasota Retina Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Midwest Eye Institute
  • Michigan
    • Warren, Michigan, United States, 48088
      • Spoor and Associates
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Eye Associates
  • Ohio
    • Columbus, Ohio, United States, 43215-7312
      • Office of Dr. Avrom Epstein, MD
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74014
      • Tulsa Clinical Research, LLC
  • Texas
    • Houston, Texas, United States, 77030
      • Retinal and Ophthalmic Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of multiple sclerosis or optic neuritis
• Evidence of temporal arteritis
• History of vasculitis or collagen vascular disease
• Previous history of NAION

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1	Drug: Diagnostic procedures; The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)	The study population consisted of adult men, first diagnosed with NAION which started within 45 days before study start and took PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) in the 1 year prior to enrollment.	Up to 45 days prior to study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1	The safety population includes participants who signed informed consent and who had any of the following collected at Visit 1 for safety: laboratory values, physical exam, any eye exams, or adverse events.	Day 1
Number of Participants With Any Adverse Events Reported at Visit 2	An adverse event is any untoward medical occurrence in a subject or clinical investigation subject and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally occurring during the trial.	From informed consent signed up to Visit 2 (Day 90+/-30)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2009
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): March 28, 2018

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 23, 2009
• First Posted (Estimate): March 24, 2009

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: sildenafil; NAION; Tadalafil; vision loss; Levitra; Viagra; optic neuropathy; PDE5 inhibitors; Cialis; Non-arteritic Anterior Ischemic Optic Neuropathy; vardenafil; acute vision loss; blurred vision; erectile dysfunction.
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Neuromuscular Diseases; Cranial Nerve Diseases; Ischemia; Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic
• Other Study ID Numbers: 12912; 2010-023586-22 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No