Optic Neuropathy, IschemicNCT00759174

A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

An observational study of Optic Neuropathy, Ischemic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 105 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 45 years and older, men only
Conditions the study is for: Optic Neuropathy, Ischemic
How many people: 673 participants
Where: 105 sitesin 6 countries
Study dates: Nov 2008to Oct 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Male aged ≥45 years;
Experienced abrupt visual change in only 1 eye

Who cannot join

Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
History of NAION or optic neuritis.
Participation in other studies within 60 days prior to entry in the study.

Trial locations and contacts

105 sites in 6 countries.

Country

City, postcode or hospital

105 sites in 6 countries

United States69 sites

Pfizer Investigational Site
Anchorage, Alaska, 99501
Pfizer Investigational Site
Ann Arbor, Michigan, 48105
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Augusta, Georgia, 30909
Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Beverly, Massachusetts, 01915
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Bradenton, Florida, 34208
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Chester, New Jersey, 07930
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Columbus, Ohio, 43215
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Dubuque, Iowa, 52002
Pfizer Investigational Site
Durham, North Carolina, 27705
Pfizer Investigational Site
Greenville, South Carolina, 29615
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Lafayette, Louisiana, 70503
Pfizer Investigational Site
Lafayette, Louisiana, 70506
Pfizer Investigational Site
Lancaster, Pennsylvania, 17602
Pfizer Investigational Site
Latham, New York, 12110
Pfizer Investigational Site
Lebanon, New Hampshire, 03756
Pfizer Investigational Site
Lisle, Illinois, 60532
Pfizer Investigational Site
Little Rock, Arkansas, 72205-7199
Pfizer Investigational Site
Little Rock, Arkansas, 72212
Pfizer Investigational Site
Loma Linda, California, 92354
Pfizer Investigational Site
Long Beach, California, 90813
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Manchester, New Hampshire, 03104
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
Mobile, Alabama, 36606
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
Newark, New Jersey, 07103
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Omaha, Nebraska, 68198
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15212
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Prairie Village, Kansas, 66208
Pfizer Investigational Site
Reno, Nevada, 89502
Pfizer Investigational Site
Richmond, Virginia, 23226
Pfizer Investigational Site
Richmond, Virginia, 23298
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Roseland, New Jersey, 07068
Pfizer Investigational Site
Ruston, Louisiana, 71270
Pfizer Investigational Site
Salt Lake City, Utah, 84132
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Southbury, Connecticut, 06488
Pfizer Investigational Site
Spartanburg, South Carolina, 29302
Pfizer Investigational Site
Spartanburg, South Carolina, 29306
Pfizer Investigational Site
St Louis, Missouri, 63104
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
Tampa, Florida, 33612
Pfizer Investigational Site
Teaneck, New Jersey, 07666
Pfizer Investigational Site
Troy, New York, 12180
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007
Pfizer Investigational Site
Washington D.C., District of Columbia, 20037
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Woodbury, New York, 11788

Other trials in United States

Germany10 sites

Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Frankfurt am Main, 60590
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Hamburg
Pfizer Investigational Site
Karlsruhe, 76133
Pfizer Investigational Site
Ludwigshafen, 67063
Pfizer Investigational Site
Mainz, 55131
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
Münster, 48149
Pfizer Investigational Site
Tübingen, 72076

Other trials in Germany

France8 sites

Pfizer Investigational Site
Amiens, 80000
Pfizer Investigational Site
Angers, Cedex 09, 49933
Pfizer Investigational Site
Dijon, 21033
Pfizer Investigational Site
Grenoble, 38043
Pfizer Investigational Site
Nantes, 44000
Pfizer Investigational Site
Paris, 75012
Pfizer Investigational Site
Paris, 75940
Pfizer Investigational Site
Strasbourg, 67091

Other trials in France

Spain8 sites

Pfizer Investigational Site
Alcalá de Henares, Madrid, 28805
Pfizer Investigational Site
Barcelona, 08206
Pfizer Investigational Site
Barcelona, 08907
Pfizer Investigational Site
Cosalada, 28822
Pfizer Investigational Site
Madrid, 28010
Pfizer Investigational Site
Madrid, 28034
Pfizer Investigational Site
Torrevieja, 03186
Pfizer Investigational Site
Valencia, 46009

Other trials in Spain

Italy7 sites

Pfizer Investigational Site
Bari, 70124
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Messina, 98124
Pfizer Investigational Site
Parma, 43100
Pfizer Investigational Site
Rome, 00133
Pfizer Investigational Site
Torino, 10122

Other trials in Italy

United Kingdom3 sites

Pfizer Investigational Site
Liverpool, L7 8XP
Pfizer Investigational Site
Manchester, M13 9WH
Pfizer Investigational Site
Scarborough, YO12 6QL

Other trials in United Kingdom

About this study

Official title: Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION

Read the detailed description

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.

Conditions: Optic Neuropathy, Ischemic
Being tested: No intervention
Keywords: Optic Neuropathy Acute NAION PDE5 Inhibitor
Medical subject headings: Optic Neuropathy, Ischemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionDrug
No intervention occurs in this observational study.

Study groups in NCT00759174
Study group	Role	What they receive
Case Group		Not described Receives: Drug: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30-day period prior to onset of NAION symptoms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Oct 2012

First posted25 Sep 2008 (estimated)
Study startNov 2008
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Optic Neuropathy, IschemicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case crossover
Time perspective: Retrospective
Enrolment: 673 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00759174
Sponsor's protocol ID: A1481259
Status last verified: Jan 2021
First submitted: 22 Sep 2008
Last updated: 1 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25358826

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
RecruitingPhase 3
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Non-Arteritic Anterior Ischemic Optic Neuropathy
RecruitingObservational study
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries

All Optic Neuropathy, Ischemic trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION
ClinicalTrials.gov ID: NCT00759174
Acronym / sponsor ID: A1481259
Conditions: Optic Neuropathy, Ischemic
Keywords: Optic Neuropathy Acute NAION PDE5 Inhibitor
Study type: Observational
Recruitment status: Completed
Enrolment: 673 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 17 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case crossover
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Case Group	–	Drug: No intervention

Who may qualify

Ages: 45 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (2 listed)

Male aged ≥45 years;
Experienced abrupt visual change in only 1 eye

Key exclusion criteria (3 listed)

Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
History of NAION or optic neuritis.
Participation in other studies within 60 days prior to entry in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionNo intervention occurs in this observational study.	Drug	Case Group

Primary outcome

Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases
Time frame: 30-day period prior to onset of NAION symptoms
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.

Results and safety

Results posted to the registry on 17 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Potential NAION Cases With PDE5i Exposure	76	76
Potential NAION Cases Without PDE5i Exposure	597	595

Primary outcome: Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases

Time frame: 30-day period prior to onset of NAION symptoms. Number. Unit: exposed days

Measure	Potential NAION Cases With PDE5i Exposure/ Case Window n = 43	Potential NAION Cases With PDE5i Exposure/ Control Window n = 43
Value	14	248

Potential NAION Cases With PDE5i Exposure/ Case Window vs Potential NAION Cases With PDE5i Exposure/ Control Window: Odds Ratio (OR): 2.15 (95% CI 1.06 to 4.34), p = 0.033, Conditional logistic regression

Population analysed: 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.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Potential NAION Cases	2 of 673 (0.3%)	0 of 673 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25358826Campbell 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Optic Neuropathy, Ischemic

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
RecruitingPhase 3
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Non-Arteritic Anterior Ischemic Optic Neuropathy
RecruitingObservational study
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

105 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Optic Neuropathy, Ischemic, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 105 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Germany, France, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases (time frame: 30-day period prior to onset of NAION symptoms). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00759174, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.