Natural History of Optic Neuritis
|ClinicalTrials.gov Identifier: NCT01851434|
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : March 29, 2018
- 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 imaging (MRI) scans is often greater than that seen in tests given during regular doctor's visits. Even though MRI is a helpful tool for studying optic neuritis and MS, more information is needed on how MS symptoms show up on MRI scans. Researchers want to use MRI scans to track changes in the optic nerve after an optic neuritis episode. This approach will help them study the relationship between optic neuritis and MS.
- To collect more information about the relationship between optic neuritis and multiple sclerosis.
- Individuals between 18 and 50 years of age who have new optic neuritis.
- Individuals between 18 and 50 years of age who have new symptoms of MS other than optic neuritis.
- Healthy volunteers between 18 and 50 years of age.
- Participants will be screened with a physical exam and medical history. They may provide blood or urine samples.
- Participants with optic neuritis or other MS symptoms will have a baseline study visit. They will have a physical exam and full eye exam. To look for signs of MS, they will have evoked potential tests to see how the body responds to stimulation. They will also have an MRI scan to study any changes in the brain and optic nerves.
- After the first visit, participants will have steroid treatment for 5 days for the optic neuritis.
- Additional study visits will be given 1, 3, 6, 9, and 12 months after the baseline visit. The tests from the first visit, including the MRI scans, will be repeated at these visits.
- Healthy volunteers will have a baseline study visit. They will have a physical exam and full eye exam. They will have evoked potential tests to see how the body responds to stimulation. They will also have an MRI scan to study any changes in the brain and optic nerves.
- Healthy volunteers will have additional study visits 2 and 11 months after the baseline visit. The tests from the first visit, including the MRI scans, will be repeated at these visits.
|Condition or disease|
The goals of this pilot study are:
- To assess the degree to which subacute changes in clinical, electrophysiological, and imaging measures can robustly predict retinal neuronal loss 12 months after acute optic neuritis.
- To construct a composite score that integrates these subacute changes, can itself robustly predict retinal neuronal loss 12 months after acute optic neuritis, can be validated in future trials, and is likely to be modulated by drugs that promote tissue repair and neuroprotection in multiple sclerosis (MS).
- To evaluate the usefulness of specialized magnetic resonance imaging (MRI) measures of the optic nerve in future clinical trials of drugs designed to promote tissue repair and neuroprotection. The primary hypothesis of the study is that peripapillary retinal nerve fiber layer (RNFL) thickness, which is generally agreed to reflect the integrity of optic nerve axons following optic neuritis, and which can be measured using spectral-domain optical coherence tomography (OCT) in the affected eye 12 months following optic neuritis, can be robustly predicted by changes in RNFL thickness between 1 and 3 months following symptom onset.
The following cohorts will be recruited at each of the three study sites:
- Up to 30 participants with acute optic neuritis.
- Up to 15 healthy volunteers who are group-wise age- and sex-matched to the participants with unilateral optic neuritis.
This is a one-year, prospective, multi-cohort, multi-site, pilot natural history study. Data obtained at NIH will be compared and aggregated with data obtained at other study sites, specifically the University of Utah-Moran Eye Center (in Salt Lake City) and Hebrew University-Hadassah Medical Center (in Jerusalem, Israel). Data will be gathered at baseline (optional) and at 1, 3, 6, 9, and 12 months in the patient cohort, and at 1, 3, and 12 months in the healthy volunteers.
The primary outcome measure is the RNFL thickness in the affected eye 12 months after optic neuritis.
Secondary outcome measures, all measured at 12 months, include:
- Measures of optic nerve structure: mean cross-sectional optic-nerve area; mean, parallel, and perpendicular diffusivity; and MTR all within the optic nerve lesion as visualized at baseline.
- Measures of brain structure: ventricular volume; T2 lesion volume along the visual pathway both sides considered together.
- Measures of retinal structure: ganglion cell layer + inner plexiform layer thickness in the affected eye.
- Measures of visual function: low-contrast letter acuity; high-contrast letter acuity; Pelli-Robson contrast sensitivity; object-from-motion detection; visual fields; and critical flicker-fusion frequency all in the affected eye.
- Measures of visual physiology: VEP amplitude; VEP latency all in the effected eye.
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||Natural History of Optic Neuritis|
|Study Start Date :||May 9, 2013|
|Actual Primary Completion Date :||October 26, 2017|
|Actual Study Completion Date :||October 26, 2017|
- Retinal nerve fiber layer in the affected eye [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851434
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Hadassah Hospital/Hebrew University Medical Center|
|Principal Investigator:||Daniel S Reich, M.D.||National Institutes of Health Clinical Center (CC)|