Optic Nerve MRI at Onset of Optic Neuritis

Principal Investigator: Bradley Katz
Keywords: optic neuritis , multiple sclerosis Department: Ophthalmology-Services
IRB Number: 00055129 Co Investigator: John  Rose
Specialty: Ophthalmology
Sub Specialties: Neuro-Ophthalmology
Recruitment Status: Active, not recruiting

Contact Information

Barbara Hart
barbara.hart@hsc.utah.edu
801-581-6459

Brief Summary

The long-term objective of this investigation is to make it possible to more quickly and efficiently evaluate the efficacy of new drugs for the treatment of optic neuritis (ON) and multiple sclerosis (MS). The direct objective of this exploratory study is to determine if the unique properties of the Utah optic nerve imaging coil improve our ability to predict outcome after acute optic neuritis. If these imaging data correlate with clinical outcomes, it may be possible to use these imaging data as surrogate markers that could be used as outcome measures in future ON and MS drug trials.

 

Inclusion Criteria

Inclusion Criteria

    1. Subjects with typical demyelinating optic neuritis based on the best clinical judgment of the investigator.
    2. Symptom onset within 4-6 weeks.
    3. Age 18 years or greater and 50 years or less. Subjects older than 50 may be enrolled if they meet all other inclusion criteria.
    4. Treatment for 3 days with IV steroids will be encouraged, but are not mandatory.
    5. Subjects treated with IV steroids will not begin study procedures until 4 weeks after their last injection.
    6. Treatment with disease modifying therapy is at the discretion of the treating physician and the patient.
    7. Female subjects must agree to use birth control if they are being treated with disease modifying therapy that requires birth control.

Exclusion Criteria

Exclusion Criteria-

  1. Previous history of MS.
  2. Previous use of disease-modifying therapy.
  • Patients may be included if they’ve previously used steroids for non-neurologic disease.
  1. Previous history of a systemic disease associated with optic neuritis (e.g. sarcoidosis, lymphoma).
  2. Presence of or history of any optic neuropathy (e.g. trauma, ischemia, glaucoma, optic nerve drusen).
  3. Previous history of a retinal disease (e.g. diabetic retinopathy, retinal drusen).
  4. Previous history of an ophthalmic disease that in the best judgment of the investigator could affect ophthalmic imaging results.
  • Subject with a history of uveitis may continue in the study.
  1. Previous history of a systemic disease that in the best judgment of the investigator could confound study outcome.
  2. Current use of a TNF alpha inhibitor (e.g. etanercept).
  3. Exposure to street drugs that in the best judgment of the investigator could confound study outcome.
  4. Pregnancy.
  5. Breast feeding if on disease modifying therapy.
  6. Subjects who have known contraindications for MRI; including cardiac pacemaker, cochlear implants, brain aneurysm clip, older stents, tattoos, and/or recently placed artificial joints.