Status:
TERMINATED
Natural History of Optic Neuritis
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Brief Summary
Background: \- Optic neuritis often is a symptom of multiple sclerosis (MS). Many people who experience optic neuritis are later diagnosed with MS. MS disease activity seen on magnetic resonance imag...
Detailed Description
Objective The goals of this pilot study are: 1. To assess the degree to which subacute changes in clinical, electrophysiological, and imaging measures can robustly predict retinal neuronal loss 12 m...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- COHORT 1: Unilateral optic neuritis.
- Typical demyelinating optic neuritis based on the best clinical judgment of the investigators.
- Symptom onset within 46 weeks of enrollment OR patients with history of optic neuritis who were followed from symptom onset under a Neuroimmunology Branch natural history or screening protocol.
- For women of childbearing potential, willing to use acceptable forms of contraception (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods (condom or diaphragm) with spermicide or they have undergone surgical sterilization (hysterectomy, tubal ligation, or vasectomy in a partner) for the study duration.
- Able to provide informed consent.
- Willing and able to participate in all aspects of the trial.
- COHORT 2: Healthy volunteers.
- No medical history that would interfere with study result interpretation, in the best clinical judgment of the investigators.
- Age greater than or equal to 18 years and less than or equal to 50 years.
- Able to provide informed consent.
- Willing and able to participate in all aspects of the trial.
- EXCLUSION CRITERIA:
- History of signs or symptoms suspicious for MS, in the best clinical judgment of the investigators.
- Pateints-Disease-modifying therapy for MS prior to the onset of the current episode of optic neuritis (excludes oral or intravenous glucocorticoids: Healthy Volunteers - Previous or current use of disease-modifying therapy for MS (excluding oral or intravenous glucocorticoids.
- Previous history of clinical optic neuritis or a systemic disease associated with optic neuritis (e.g. sarcoidosis, lymphoma).
- Current or prior optic neuropathy (e.g. trauma, ischemia, glaucoma, optic nerve drusen).
- Previous history of a retinal disease (e.g. diabetic retinopathy, retinal drusen) other than uveitis.
- Previous history of an ophthalmic disease that in the best judgment of the investigator could affect ophthalmic imaging results.
- Previous history of a systemic disease that may mimic MS (e.g. neurosyphilis, neurosarcoidosis, CNS ymphoma, Si(SqrRoot)(Delta)gren s syndrome).
- Previous history of a systemic disease that in the best judgment of the investigator could confound study outcome.
- Current use of a TNF-alpha inhibitor (e.g. etanercept).
- Habitual use of illicit drugs that in the best judgment of the investigators could confound study outcome.
- Pregnant or breast-feeding.
- Unwilling to co-enroll on a Neuroimmunology Branch natural history or screening protocol currently 89-N-0045.
- Contraindication to MRI scanning.
Exclusion
Key Trial Info
Start Date :
March 20 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 26 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01851434
Start Date
March 20 2013
End Date
October 26 2017
Last Update
September 29 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
2
University of Utah
Salt Lake City, Utah, United States, 84112
3
Hadassah Hospital/Hebrew University Medical Center
Jerusalem, Israel