A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01131104 |
Recruitment Status
:
Completed
First Posted
: May 26, 2010
Results First Posted
: April 5, 2018
Last Update Posted
: April 5, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Nonarteritic Anterior Ischemic Optic Neuropathy | Drug: PDE5 Inhibitors |
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 2010 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |
Group/Cohort | 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:
|
- 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use [ Time Frame: 30 days prior to NAION onset ]Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131104

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 |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT01131104 History of Changes |
Other Study ID Numbers: |
11638 H6D-MC-LVHQ ( Other Identifier: Eli Lilly and Company ) |
First Posted: | May 26, 2010 Key Record Dates |
Results First Posted: | April 5, 2018 |
Last Update Posted: | April 5, 2018 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Eli Lilly and Company:
NAION |
Additional relevant MeSH terms:
Ischemia Optic Nerve Diseases Optic Neuropathy, Ischemic Pathologic Processes Cranial Nerve Diseases Nervous System Diseases Eye Diseases |
Vascular Diseases Cardiovascular Diseases Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |