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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Potential Neuroprotection With ACTHAR Following 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 Summary: Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
Sponsor: Neuro-Ophthalmologic Associates, PC

Current Primary Outcome: Neuro-protection [ Time Frame: 12 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Preservation of retinal nerve fiber layer. [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Neuro-Ophthalmologic Associates, PC

Dates:
Date Received: November 6, 2013
Date Started: November 2013
Date Completion: December 2016
Last Updated: September 20, 2016
Last Verified: September 2016