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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVHQ | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with NAION who have used PDE5 inhibitors |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDE5 Inhibitors | Drug | Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use | Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION. | 30 days prior to NAION onset |
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Inclusion Criteria:
Exclusion Criteria:
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Potential cases of acute NAION will be prospectively identified by approximately 20 neuro-ophthalmology centers in the US
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35295 | United States | ||
| Cockerham Eye Consultant |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Set | Enrolled participants who met inclusion/exclusion criteria and had physician-diagnosed NAION with a known date of onset. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Los Altos |
| California |
| 94024 |
| United States |
| Precision Eye Care | National City | California | 91950 | United States |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | United States |
| Russell P Edwards M.D. | San Diego | California | 92103 | United States |
| Pacific Eye Associates | San Francisco | California | 94115 | United States |
| Eye Surgical & Medical Associates, Inc. | Visalia | California | 93277 | United States |
| The Eye Care Group | New Haven | Connecticut | 06708 | United States |
| Avail Clinical Research LLC | DeLand | Florida | 32720 | United States |
| University of Florida - Gainesville | Gainesville | Florida | 32611 | United States |
| Florida Retina Consultants | Lakeland | Florida | 33805 | United States |
| University of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| USF Eye Institute | Tampa | Florida | 33612 | United States |
| University of Illinois At Chicago Med Center | Chicago | Illinois | 60612 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Northshore Eye and Vision Center | Glenview | Illinois | 60026 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Univ KY Clinical Resch Org- KY Clinic | Lexington | Kentucky | 40536 | United States |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States |
| Bethesda Neurology, LLC | Bethesda | Maryland | 20814 | United States |
| Longwood Medical Eye Center | Boston | Massachusetts | 02215 | United States |
| Atlantic Clinical Trials, LLC | Watertown | Massachusetts | 02472 | United States |
| Henry Ford Health System | Dearborn | Michigan | 48126 | United States |
| Neuro-Ophthalmic Services | Royal Oak | Michigan | 48073 | United States |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55455 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| JFK Medical Center, NJ Neuroscience Institute | Edison | New Jersey | 08820 | United States |
| Stony Brook University Medical Center | East Setauket | New York | 11733 | United States |
| E.S. Harkness Eye Institute | New York | New York | 10032 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | United States |
| Ohio State Univ College Of Medicine | Columbus | Ohio | 46210 | United States |
| Dr. Daniel Lin | Oregon | Ohio | 43616 | United States |
| Family Eye Care | Lancaster | Pennsylvania | 17601 | United States |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny Ophthalmic & Orbital Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Retina Consultants of Charleston | Charleston | South Carolina | 29414 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Neuro-Opthalmology of Texas | Houston | Texas | 77030 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| University of Washington Medical Center | Seattle | Washington | 98104 | United States |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | United States |
| Study Set |
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| Adjudication-Confirmed NAION Set |
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| 30-Day Analysis Set | Participants had adjudication-confirmed NAION and complete PDE5 inhibitor information. |
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| 42-Day Analysis Set | Participants had adjudication-confirmed NAION and complete PDE5 inhibitor information. |
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| 12-Month Analysis Set | Participants had adjudication-confirmed NAION and complete PDE5 inhibitor information. |
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| COMPLETED |
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| NOT COMPLETED |
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Participants with adjudication-confirmed NAION.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants with NAION who have used PDE5 inhibitors |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Adjudicated NAION Participants within the 30-Day Analysis Set | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use | Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION. | All participants in the 30 day analysis set. | Posted | Number | 95% Confidence Interval | Relative risk of exposure | 30 days prior to NAION onset | Participant days | Participant days |
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No serious adverse events or other adverse events were assessed or collected, with the exception of NAION.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Participants with NAION who have used PDE5 inhibitors. | 0 | 345 | 0 | 345 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D018917 | Optic Neuropathy, Ischemic |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058986 | Phosphodiesterase 5 Inhibitors |
| D000068581 | Tadalafil |
| D000068677 | Sildenafil Citrate |
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D010726 | Phosphodiesterase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D011687 | Purines |
| D007093 | Imidazoles |
| D001393 | Azoles |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| Caucasian |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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