Trial Condition(s):

Anterior Ischemic Optic Neuropathy

PDE5 inhibitor use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Bayer Identifier:

12912

ClinicalTrials.gov Identifier:

NCT00867815

EudraCT Number:

2010-023586-22

Terminated/Withdrawn

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.

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

Trial Summary

Enrollment Goal
10
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Midwest Eye Institute

Indianapolis, United States, 46290

Status
Terminated
 
Locations

Sarasota Retina Institute

Sarasota, United States, 34239

Status
Completed
 
Locations

Spoor and Associates

Warren, United States, 48088

Status
Terminated
 
Locations

West Coast Eye Care

Fort Myers, United States, 33908

Status
Completed
 
Locations

Retinal and Ophthalmic Consultants

Houston, United States, 77030

Status
Completed
 
Locations

Palm Beach Eye Center

Atlantis, United States, 33461

Status
Completed
 
Locations

Asheville Eye Associates

Asheville, United States, 28803

Status
Terminated
 
Locations

Office of Dr. Avrom Epstein, MD

Columbus, United States, 43215-7312

Status
Completed
 
Locations

Midwest Eye Institute

Toronto, Canada, M5G 1X5

Status
Completed
 
Locations

National Ophthalmic Research Institute

Fort Myers, United States, 33912

Status
Completed
 
Locations

Greider Eye Associates

Vista, United States, 92083

Status
Terminated
 
Locations

Tulsa Clinical Research, LLC

Tulsa, United States, 74014

Status
Completed
 
Locations

Save Sight Institute

Sydney, Australia, 2000

Status
Completed
 

Trial Design