A Study to Determine if There is a Possible Association Between Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) and Phosphodiesterase Type 5 (PDE5) Inhibitors
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01131104
First received: May 10, 2010
Last updated: December 4, 2014
Last verified: December 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Nonarteritic Anterior Ischemic Optic Neuropathy |
Drug: PDE5 Inhibitors |
| Study Type: | Observational |
| Study Design: | 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) |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Number of patients with adjudicated NAION diagnosis and who are non-chronic users of PDE5 inhibitors. [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cohort 1
Patients 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Potential cases of acute NAION will be prospectively identified by approximately 20 neuro-ophthalmology centers in the US
Criteria
Inclusion Criteria:
- Adult male subjects, at least 18 years of age, who are willing to participate in the study
- Patients 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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131104
Show 43 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131104
Contacts
| Contact: There may be multiple sites in this observational study 1-877-CTLILLY (1-877-285-4559) | 317-615-4559 |
Show 43 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01131104 History of Changes |
| Other Study ID Numbers: | 11638, H6D-MC-LVHQ |
| Study First Received: | May 10, 2010 |
| Last Updated: | December 4, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
NAION |
Additional relevant MeSH terms:
|
Optic Nerve Diseases Optic Neuropathy, Ischemic Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases |
Vascular Diseases Phosphodiesterase 5 Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Phosphodiesterase Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2015