NCT01851434

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 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. Objectives: \- To collect more information about the relationship between optic neuritis and multiple sclerosis. Eligibility:

  • 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. Design:
  • 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

May 9, 2013

Last Update Submit

September 27, 2022

Conditions

Multiple Sclerosis

Keywords

OCTMultiple SclerosisOptic NeuritisMagnetic Resonance Imaging (MRI)Natural History

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is the RNFL thickness in the affected eye 12 months after optic neuritis

    RNFL thickness in the affected eye 12 months after optic neuritis.

    12 months after optic neuritis

Study Arms (2)

healthy volunteers

age- and sex-matched to the participants with unilateral optic neuritis and a brain MRI suggestive of MS

Patients with unilateral optic neuritis

Recruitment will proceed until 10 participants with a brain MRI suggestive of MS (obtained at any time point during the study) have completed the study.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

\- Up to 30 participants with unilateral optic neuritis. Recruitment will proceed until 10 participants with a brain MRI suggestive of MS (obtained at any time point during the study) have completed the study. - Up to 15 healthy volunteers, age- and sex-matched to the participants with unilateral optic neuritis and a brain MRI suggestive of MS.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Hadassah Hospital/Hebrew University Medical Center

Jerusalem, Israel

Location

Related Publications (3)

  • Leaney J, Klistorner A, Arvind H, Graham SL. Dichoptic suppression of mfVEP amplitude: effect of retinal eccentricity and simulated unilateral visual impairment. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6549-55. doi: 10.1167/iovs.10-5769. Epub 2010 Jul 29.

    PMID: 20671270BACKGROUND

  • Klistorner A, Arvind H, Garrick R, Yiannikas C, Paine M, Graham SL. Remyelination of optic nerve lesions: spatial and temporal factors. Mult Scler. 2010 Jul;16(7):786-95. doi: 10.1177/1352458510371408. Epub 2010 Jun 7.

    PMID: 20530125BACKGROUND

  • Klistorner A, Arvind H, Garrick R, Graham SL, Paine M, Yiannikas C. Interrelationship of optical coherence tomography and multifocal visual-evoked potentials after optic neuritis. Invest Ophthalmol Vis Sci. 2010 May;51(5):2770-7. doi: 10.1167/iovs.09-4577. Epub 2009 Dec 30.

    PMID: 20042660BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple SclerosisOptic Neuritis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Daniel S Reich, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 10, 2013

Study Start

March 20, 2013

Primary Completion

September 5, 2014

Study Completion

October 26, 2017

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations

US(2)IL(1)