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.
Verified August 2012 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: August 10, 2012
Last verified: August 2012
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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:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
U.S. FDA Resources
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: | 125 |
| 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
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 |
Locations
| United States, California | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Petaluma, California, United States, 94954 | |
| Contact: Eli Lilly | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Eli Lilly | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Visalia, California, United States, 93277 | |
| Contact: Eli Lilly | |
| United States, Florida | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Boyton Beach, Florida, United States, 33437 | |
| Contact: Eli Lilly | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Sarasota, Florida, United States, 34239 | |
| Contact: Eli Lilly | |
| United States, Illinois | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Chicago, Illinois, United States, 60616 | |
| Contact: Eli Lilly | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Glenview, Illinois, United States, 60026 | |
| Contact: Eli Lilly | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Wheaton, Illinois, United States, 60187 | |
| Contact: Eli Lilly | |
| United States, Michigan | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Eli Lilly | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Saginaw, Michigan, United States, 48603 | |
| Contact: Eli Lilly | |
| United States, New Jersey | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Edison, New Jersey, United States, 08820 | |
| Contact: Eli Lilly | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Somerset, New Jersey, United States, 08873 | |
| Contact: Eli Lilly | |
| United States, New York | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Eli Lilly | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Eli Lilly | |
| United States, North Carolina | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Eli Lilly | |
| United States, Ohio | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Oregon, Ohio, United States, 43616 | |
| Contact: Eli Lilly | |
| United States, South Carolina | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Charleston, South Carolina, United States, 29414 | |
| Contact: Eli Lilly | |
| United States, South Dakota | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Rapid City, South Dakota, United States, 57701 | |
| Contact: Eli Lilly | |
| United States, Tennessee | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Chattanooga, Tennessee, United States, 37421 | |
| Contact: Eli Lilly | |
| United States, Texas | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| San Antonio, Texas, United States, 78240 | |
| Contact: Eli Lilly | |
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: | August 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
NAION |
Additional relevant MeSH terms:
|
Nerve Compression Syndromes Ischemia Optic Nerve Diseases Optic Neuropathy, Ischemic Demyelinating Diseases Polyneuropathies Neurologic Manifestations Neurotoxicity Syndromes Pathologic Processes Cranial Nerve Diseases Nervous System Diseases Eye Diseases |
Vascular Diseases Cardiovascular Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Poisoning Substance-Related Disorders Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013