Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis

Early Phase 1CompletedNCT01987167

Neuro-Ophthalmologic Associates, PC25 enrolled

Overview

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.

Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Optic Neuritis

Interventions

ACTHARDRUG

Injectable Gel

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Neuro Ophthalmology

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Neuro-protection

Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.

Time frame: 12 months

Secondary Outcomes

Preservation of retinal nerve fiber layer.

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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