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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023586-22 | EudraCT Number |
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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.
Collected data will be compared to historic data of the same participant in case-crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic procedures | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greider Eye Associates | Vista | California | 92083 | United States | ||
| Palm Beach Eye Center |
There were 10 screening failures. The primary reasons for screen failure are protocol violation (8 participants) and consent withdrawn (2 participants)
The study started on 13 JUL 2009 (FPFV) and the date of last visit was 29 DEC 2017 (LPLV).
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| ID | Title | Description |
|---|---|---|
| FG000 | PDE5 Inhibitor Use & Risk of NAION | Participants were assessed at 2 visits. Visit 1 (Day 1) included screening, confirmation of the diagnosis of NAION, enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90+/-30) was a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION. No interventional treatment was administered in the context of this study. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2016 | Jan 21, 2019 |
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| 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) |
| Atlantis |
| Florida |
| 33461 |
| United States |
| West Coast Eye Care | Fort Myers | Florida | 33908 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Spoor and Associates | Warren | Michigan | 48088 | United States |
| Asheville Eye Associates | Asheville | North Carolina | 28803 | United States |
| Office of Dr. Avrom Epstein, MD | Columbus | Ohio | 43215-7312 | United States |
| Tulsa Clinical Research, LLC | Tulsa | Oklahoma | 74014 | United States |
| Retinal and Ophthalmic Consultants | Houston | Texas | 77030 | United States |
| Save Sight Institute | Sydney | New South Wales | 2000 | Australia |
| Midwest Eye Institute | Toronto | Ontario | M5G 1X5 | Canada |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | PDE5 Inhibitor Use & Risk of NAION | Participants were assessed at 2 visits. Visit 1 (Day 1) included screening, confirmation of the diagnosis of NAION, enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90+/-30) was a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION. No interventional treatment was administered in the context of this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | 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. | Posted | Count of Participants | Participants | Up to 45 days prior to study enrollment |
|
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Day 1 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | From informed consent signed up to Visit 2 (Day 90+/-30) |
|
|
From inform consent signed up to approximately 3 months after first diagnosis 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 | PDE5 Inhibitor Use & Risk of NAION | Participants were assessed at 2 visits. Visit 1 (Day 1) included screening, confirmation of the diagnosis of NAION, enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90+/-30) was a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION. No interventional treatment was administered in the context of this study. | 0 | 10 | 1 | 10 | 2 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Optic ischaemic neuropathy | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
|
Study was prematurely terminated, hence no statistical analysis was performed due to small sample of population.
The agreed point of publication is 12-18 months after database lock at the earliest.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2018 | Jan 21, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018917 | Optic Neuropathy, Ischemic |
| D001766 | Blindness |
| D014786 | Vision Disorders |
| D009901 | Optic Nerve Diseases |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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