A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01131104
• Collaborator: (none)
• Enrollment: 345
• Locations: 44
• Duration (Months): 67
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.

Condition or Disease	Intervention/Treatment	Phase
Nonarteritic Anterior Ischemic Optic Neuropathy	Drug: PDE5 Inhibitors

Study Design

• Study Type: Observational
• Actual Enrollment: 345 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: A Prospective Case-crossover Study to Evaluate the Possible Association Between the Use of PDE5 Inhibitors and the Risk of Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Participants with NAION who have used PDE5 inhibitors	Drug: PDE5 Inhibitors; Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.; Other Names: tadalafil sildenafil vardenafil

Outcome Measures

Primary Outcome Measures

1. 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use [30 days prior to NAION onset]

   Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult male subjects, at least 18 years of age, who are willing to participate in the study

• Participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of NAION symptoms to an ophthalmologist that resulted in a diagnosis of Suspected NAION by the investigator

Exclusion Criteria:

• Previous history of NAION

• Previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis

• History of glaucoma in either one or both eyes

• History of multiple sclerosis or diagnostic testing evidence of optic neuritis

• Have dementia or other reasons for memory impairment in the opinion of the investigator

• Have participated in other non-observational studies within 3 months of NAION onset

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Birmingham	Birmingham	Alabama	United States	35295
2	Cockerham Eye Consultant	Los Altos	California	United States	94024
3	Precision Eye Care	National City	California	United States	91950
4	North Bay Eye Associates, Inc.	Petaluma	California	United States	94954
5	Russell P Edwards M.D.	San Diego	California	United States	92103
6	Pacific Eye Associates	San Francisco	California	United States	94115
7	Eye Surgical & Medical Associates, Inc.	Visalia	California	United States	93277
8	The Eye Care Group	New Haven	Connecticut	United States	06708
9	Avail Clinical Research LLC	DeLand	Florida	United States	32720
10	University of Florida - Gainesville	Gainesville	Florida	United States	32611
11	Florida Retina Consultants	Lakeland	Florida	United States	33805
12	University of Miami School of Medicine	Miami	Florida	United States	33136
13	Sarasota Retina Institute	Sarasota	Florida	United States	34239
14	USF Eye Institute	Tampa	Florida	United States	33612
15	University of Illinois At Chicago Med Center	Chicago	Illinois	United States	60612
16	Northwestern University	Evanston	Illinois	United States	60208
17	Northshore Eye and Vision Center	Glenview	Illinois	United States	60026
18	Midwest Eye Institute	Indianapolis	Indiana	United States	46290
19	Univ KY Clinical Resch Org- KY Clinic	Lexington	Kentucky	United States	40536
20	Paducah Retinal Center	Paducah	Kentucky	United States	42001
21	Bethesda Neurology, LLC	Bethesda	Maryland	United States	20814
22	Longwood Medical Eye Center	Boston	Massachusetts	United States	02215
23	Atlantic Clinical Trials, LLC	Watertown	Massachusetts	United States	02472
24	Henry Ford Health System	Dearborn	Michigan	United States	48126
25	Neuro-Ophthalmic Services	Royal Oak	Michigan	United States	48073
26	University of Minnesota Medical School	Minneapolis	Minnesota	United States	55455
27	Saint Louis University	Saint Louis	Missouri	United States	63104
28	JFK Medical Center, NJ Neuroscience Institute	Edison	New Jersey	United States	08820
29	Stony Brook University Medical Center	East Setauket	New York	United States	11733
30	E.S. Harkness Eye Institute	New York	New York	United States	10032
31	Montefiore Medical Center	The Bronx	New York	United States	10467
32	PMG Research of Salisbury	Salisbury	North Carolina	United States	28144
33	Ohio State Univ College Of Medicine	Columbus	Ohio	United States	46210
34	Dr. Daniel Lin	Oregon	Ohio	United States	43616
35	Family Eye Care	Lancaster	Pennsylvania	United States	17601
36	University of Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19104
37	Allegheny Ophthalmic & Orbital Associates	Pittsburgh	Pennsylvania	United States	15212
38	Retina Consultants of Charleston	Charleston	South Carolina	United States	29414
39	Black Hills Regional Eye Institute	Rapid City	South Dakota	United States	57701
40	Neuro-Opthalmology of Texas	Houston	Texas	United States	77030
41	Medical Center Ophthalmology Associates	San Antonio	Texas	United States	78240
42	University of Utah Health Sciences Center	Salt Lake City	Utah	United States	84132
43	University of Washington Medical Center	Seattle	Washington	United States	98104
44	Swedish Neuroscience Institute	Seattle	Washington	United States	98122

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fr- 9 AM-5 PM Eastern time (UTC?GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01131104
• Other Study ID Numbers: 11638; H6D-MC-LVHQ
• First Posted: May 26, 2010
• Last Update Posted: Apr 5, 2018
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Eli Lilly and Company: NAION
• Additional relevant MeSH terms: Optic Nerve Diseases; Optic Neuropathy, Ischemic; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride; Phosphodiesterase 5 Inhibitors

Study Results

Participant Flow

Pre-assignment Detail	Study Set were enrolled participants who met inclusion/exclusion criteria and physician-diagnosed Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)known date of onset. Adjudication-Confirmed NAION Set were confirmed participants (by adjudication committee) with inclusion/exclusion criteria and physician-diagnosed NAION known date of onset.

Arm/Group Title	Enrolled Set
Arm/Group Description	Enrolled participants who met inclusion/exclusion criteria and had physician-diagnosed NAION with a known date of onset.
Period Title: Overall Study
STARTED	345
Study Set	344
Adjudication-Confirmed NAION Set	279
30-Day Analysis Set	24
42-Day Analysis Set	28
12-Month Analysis Set	26
COMPLETED	332
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	Cohort 1
Arm/Group Description	Participants with NAION who have used PDE5 inhibitors
Overall Participants	279
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.5 (10.70)
Sex/Gender, Customized (Count of Participants)
Female	0 0%
Male	279 100%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 0.7%
Native Hawaiian or Other Pacific Islander	1 0.4%
Black or African American	2 0.7%
Caucasian	267 95.7%
More than one race	2 0.7%
Unknown or Not Reported	5 1.8%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	11 3.9%
Not Hispanic or Latino	265 95%
Unknown or Not Reported	3 1.1%
Region of Enrollment (Count of Participants)
United States	279 100%
Adjudicated NAION Participants within the 30-Day Analysis Set (Count of Participants)
Count of Participants [Participants]	24 8.6%

Outcome Measures

1. Primary Outcome

Title	30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
Description	Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
Time Frame	30 days prior to NAION onset

Outcome Measure Data

Analysis Population Description

All participants in the 30 day analysis set.

Arm/Group Title	Cohort 1
Arm/Group Description	Participants with NAION who have used PDE5 inhibitors
Measure Participants	24
Measure Participant days	720
Number (95% Confidence Interval) [Relative risk of exposure]	2.27

Adverse Events

Adverse Event Reporting Description	No serious adverse events or other adverse events were assessed or collected, with the exception of NAION.
Arm/Group Title	Cohort 1
Arm/Group Description	Participants with NAION who have used PDE5 inhibitors.
All Cause Mortality
	Cohort 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cohort 1
	Affected / at Risk (%)	# Events
Total	0/345 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1
	Affected / at Risk (%)	# Events
Total	0/345 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.