Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.
Sites will identify patients who meet the entry criteria during the conduct of their normal practice. Patients meeting these criteria will be offered participation in the study after reading and completing an informed consent document.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Drug | No intervention occurs in this observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases | Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows. | 30-day period prior to onset of NAION symptoms |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases | Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Potential cases of acute NAION will be prospectively identified by approximately 125 ophthalmology centers in the US and Europe. Patients must have presented to an ophthalmologist within 3 weeks of symptom onset.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25358826 | Derived | Campbell UB, Walker AM, Gaffney M, Petronis KR, Creanga D, Quinn S, Klein BE, Laties AM, Lewis M, Sharlip ID, Kolitsopoulos F, Klee BJ, Mo J, Reynolds RF. Acute nonarteritic anterior ischemic optic neuropathy and exposure to phosphodiesterase type 5 inhibitors. J Sex Med. 2015 Jan;12(1):139-51. doi: 10.1111/jsm.12726. Epub 2014 Oct 31. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Potential NAION Cases With PDE5i Exposure | Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| 30-day period prior to onset of NAION symptoms |
| Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases | Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows. | 60-day period prior to onset of NAION symptoms |
| Mobile |
| Alabama |
| 36606 |
| United States |
| Pfizer Investigational Site | Anchorage | Alaska | 99501 | United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205-7199 | United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72212 | United States |
| Pfizer Investigational Site | Loma Linda | California | 92354 | United States |
| Pfizer Investigational Site | Long Beach | California | 90813 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90033 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90095 | United States |
| Pfizer Investigational Site | Oceanside | California | 92056 | United States |
| Pfizer Investigational Site | Pasadena | California | 91105 | United States |
| Pfizer Investigational Site | Aurora | Colorado | 80045 | United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06510 | United States |
| Pfizer Investigational Site | Southbury | Connecticut | 06488 | United States |
| Pfizer Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20037 | United States |
| Pfizer Investigational Site | Bradenton | Florida | 34208 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33612 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30322 | United States |
| Pfizer Investigational Site | Augusta | Georgia | 30909 | United States |
| Pfizer Investigational Site | Lisle | Illinois | 60532 | United States |
| Pfizer Investigational Site | Dubuque | Iowa | 52002 | United States |
| Pfizer Investigational Site | Prairie Village | Kansas | 66208 | United States |
| Pfizer Investigational Site | Lafayette | Louisiana | 70503 | United States |
| Pfizer Investigational Site | Lafayette | Louisiana | 70506 | United States |
| Pfizer Investigational Site | Ruston | Louisiana | 71270 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21204 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21287 | United States |
| Pfizer Investigational Site | Beverly | Massachusetts | 01915 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02114 | United States |
| Pfizer Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48105 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63104 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68198 | United States |
| Pfizer Investigational Site | Reno | Nevada | 89502 | United States |
| Pfizer Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| Pfizer Investigational Site | Manchester | New Hampshire | 03104 | United States |
| Pfizer Investigational Site | Chester | New Jersey | 07930 | United States |
| Pfizer Investigational Site | Newark | New Jersey | 07103 | United States |
| Pfizer Investigational Site | Roseland | New Jersey | 07068 | United States |
| Pfizer Investigational Site | Teaneck | New Jersey | 07666 | United States |
| Pfizer Investigational Site | Latham | New York | 12110 | United States |
| Pfizer Investigational Site | Rochester | New York | 14642 | United States |
| Pfizer Investigational Site | Stony Brook | New York | 11794 | United States |
| Pfizer Investigational Site | Troy | New York | 12180 | United States |
| Pfizer Investigational Site | Woodbury | New York | 11788 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27705 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45242 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43215 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | Lancaster | Pennsylvania | 17602 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29425 | United States |
| Pfizer Investigational Site | Greenville | South Carolina | 29615 | United States |
| Pfizer Investigational Site | Spartanburg | South Carolina | 29302 | United States |
| Pfizer Investigational Site | Spartanburg | South Carolina | 29306 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84132 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23226 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23298 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98104 | United States |
| Pfizer Investigational Site | Angers | Cedex 09 | 49933 | France |
| Pfizer Investigational Site | Amiens | 80000 | France |
| Pfizer Investigational Site | Dijon | 21033 | France |
| Pfizer Investigational Site | Grenoble | 38043 | France |
| Pfizer Investigational Site | Nantes | 44000 | France |
| Pfizer Investigational Site | Paris | 75012 | France |
| Pfizer Investigational Site | Paris | 75940 | France |
| Pfizer Investigational Site | Strasbourg | 67091 | France |
| Pfizer Investigational Site | Berlin | 13353 | Germany |
| Pfizer Investigational Site | Frankfurt am Main | 60590 | Germany |
| Pfizer Investigational Site | Freiburg im Breisgau | 79106 | Germany |
| Pfizer Investigational Site | Hamburg | Germany |
| Pfizer Investigational Site | Karlsruhe | 76133 | Germany |
| Pfizer Investigational Site | Ludwigshafen | 67063 | Germany |
| Pfizer Investigational Site | Mainz | 55131 | Germany |
| Pfizer Investigational Site | München | 81675 | Germany |
| Pfizer Investigational Site | Münster | 48149 | Germany |
| Pfizer Investigational Site | Tübingen | 72076 | Germany |
| Pfizer Investigational Site | Bari | 70124 | Italy |
| Pfizer Investigational Site | Bologna | 40138 | Italy |
| Pfizer Investigational Site | Florence | 50134 | Italy |
| Pfizer Investigational Site | Messina | 98124 | Italy |
| Pfizer Investigational Site | Parma | 43100 | Italy |
| Pfizer Investigational Site | Rome | 00133 | Italy |
| Pfizer Investigational Site | Torino | 10122 | Italy |
| Pfizer Investigational Site | Alcalá de Henares | Madrid | 28805 | Spain |
| Pfizer Investigational Site | Barcelona | 08206 | Spain |
| Pfizer Investigational Site | Barcelona | 08907 | Spain |
| Pfizer Investigational Site | Cosalada | 28822 | Spain |
| Pfizer Investigational Site | Madrid | 28010 | Spain |
| Pfizer Investigational Site | Madrid | 28034 | Spain |
| Pfizer Investigational Site | Torrevieja | 03186 | Spain |
| Pfizer Investigational Site | Valencia | 46009 | Spain |
| Pfizer Investigational Site | Liverpool | L7 8XP | United Kingdom |
| Pfizer Investigational Site | Manchester | M13 9WH | United Kingdom |
| Pfizer Investigational Site | Scarborough | YO12 6QL | United Kingdom |
| Potential NAION Cases Without PDE5i Exposure |
Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Potential NAION Cases With PDE5i Exposure | Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. |
| BG001 | Potential NAION Cases Without PDE5i Exposure | Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| 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 Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases | Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows. | Full Analysis Set (FAS) included all participants who signed informed consent, were eligible for study, reported exposure to PDE5i within 60 days prior to participant-reported onset of NAION symptoms. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset. | Posted | Number | exposed days | 30-day period prior to onset of NAION symptoms | Days | Days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases | Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows. | FAS included all participants who signed informed consent, were eligible for study and reported exposure to PDEi within 60 days prior to participant reported-onset of NAION symptoms. N (number of participants analyzed) represents Definite or Possible NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset. | Posted | Number | exposed days | 30-day period prior to onset of NAION symptoms | Days | Days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases | Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows. | FAS population. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days or every week within 60 days prior to symptom onset. | Posted | Number | exposed weeks | 60-day period prior to onset of NAION symptoms | Weeks | Weeks |
|
Not provided
Given retrospective data collection, adverse events may have occurred prior to informed consent.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Potential NAION Cases | All participants who met pre-defined potential acute NAION criteria and were either exposed or not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. | 2 | 673 | 0 | 673 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
Not provided
Potential for bias from inaccuracies in recall of exposure and exposure-based enrollment were evaluated. Although these sources of bias cannot be excluded, they were unlikely to have substantially affected the primary results.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| 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 |
Not provided
Not provided
| Male |
|
Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window. |
|
|
|
|
|
|