NCT00867815

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_4

Geographic Reach
3 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

July 13, 2009

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

8.5 years

First QC Date

March 23, 2009

Results QC Date

December 26, 2018

Last Update Submit

January 21, 2019

Conditions

Anterior Ischemic Optic Neuropathy

Keywords

Non-arteritic Anterior Ischemic Optic NeuropathyNAIONPDE5 inhibitorsvardenafilLevitrasildenafilViagraTadalafilCialisacute vision lossvision lossblurred visionoptic neuropathyerectile dysfunction.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1

    Day 1

  • Number of Participants With Any Adverse Events Reported at Visit 2

    From informed consent signed up to Visit 2 (Day 90+/-30)

Study Arms (1)

Arm 1

OTHER
Drug: Diagnostic procedures

Interventions

Diagnostic proceduresDRUG

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

Arm 1

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Greider Eye Associates

Vista, California, 92083, United States

Location

Palm Beach Eye Center

Atlantis, Florida, 33461, United States

Location

West Coast Eye Care

Fort Myers, Florida, 33908, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Spoor and Associates

Warren, Michigan, 48088, United States

Location

Asheville Eye Associates

Asheville, North Carolina, 28803, United States

Location

Office of Dr. Avrom Epstein, MD

Columbus, Ohio, 43215-7312, United States

Location

Tulsa Clinical Research, LLC

Tulsa, Oklahoma, 74014, United States

Location

Retinal and Ophthalmic Consultants

Houston, Texas, 77030, United States

Location

Save Sight Institute

Sydney, New South Wales, 2000, Australia

Location

Midwest Eye Institute

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Optic Neuropathy, IschemicBlindnessVision DisordersOptic Nerve DiseasesErectile Dysfunction

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Limitations and Caveats

Study was prematurely terminated, hence no statistical analysis was performed due to small sample of population.

Results Point of Contact

Title
Therapeutic Area Head
Organization
Bayer
clinical-trials-contact@bayer.com
(+) 1-888-8422937

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 24, 2009

Study Start

July 13, 2009

Primary Completion

December 29, 2017

Study Completion

March 28, 2018

Last Updated

January 23, 2019

Results First Posted

January 23, 2019

Record last verified: 2019-01

Locations

CA(1)US(11)AU(1)