Optic Neuritis
Conditions
Keywords
acute optic neuritis
Brief summary
The goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
Detailed description
Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
Interventions
DRUGACTHAR
Injectable Gel
Sponsors
Mallinckrodt
Neuro-Ophthalmologic Associates, PC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* unilateral acute demyelinating optic neuritis * Able to provide informed consent * age 18 or older * can perform the above listed electrophysiologic diagnostic testing * can perform high and low contrast visual acuity and visual field perimetry
Exclusion criteria
* prior diagnosis of remitting/relapsing multiple sclerosis(RRMS) * secondary progressive MS(SPMS) * primary progressive MS (PPMS) * undergoing treatment with medications approve for treatment of RRMS(except corticosteroids for a condition not involving central nervous system demyelination) * prior diagnosis of systemic lupus erythematosis * mixed connective tissue disease * vasculitis * sarcoidosis * neuro-myelitis optica
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuro-protection | 12 months | Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preservation of retinal nerve fiber layer. | 12 months | To define the objective (micron thickness, volumetric analysis) and subjective (histopathological changes) of spectral domain optical coherence tomography (SD-OCT) at the time of clinical presentation of acute optic neuritis and during 6 months of recovery following ACTHAR treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Preservation and/or restoration of electrophysiological parameters for patients with acute optic neuritis. | 12 months | To define the electrophysiological changes at the onset and following an acute event of optic neuritis with Multifocal electroretinography(mERG) and visual evoked potentials (VEP) |
| Structural, Physiological and Metabolic changes during an acute event of optic neuritis | 12 months | to determine the earliest structural, physiological, and metabolic changes in the optic nerve during an acute event of demyelinating optic neuritis and the natural history of these changes over 6 months. |
Countries
United States
Outcome results
None listed