A Trial of Neuroprotection With ACTH in Acute Optic Neuritis
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of ACTH will
reduce axonal loss following ON by limiting inflammatory optic nerve injury. We will compare
the effect of ACTH and intravenous methylprednisolone therapy on axonal injury following ON
using OCT, a sensitive, reproducible and noninvasive tool to measure RNFL thickness.
The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified
statistical analyses will compare the difference in the mean RNFL thickness at 6 months in
the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean
6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The
secondary outcome measure will examine the frequency of optic nerves with RNFL swelling
between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. A predefined
exploratory outcome will compare the ganglion cell plus inner plexiform layer (GC+IPL)
thickness at 6 months between treatment groups. Additional tertiary outcome will be the
assessment of changes in fatigue, mood, visual function depression, and quality of life in
patients with AON. Assessment will be completed by administration of the following
questionnaires: Modified Fatigue Impact Scale, Multiple Sclerosis Quality of Life 54
Instrument, 25-item Visual Function Questionnaire with 10-item supplement, Beck's Depression
Inventory. These questionnaires have been validated for the MS (AON) population. Descriptive
and correlative analysis will be done at each visit time point to assess for QOL for this
study population.
Phase:
Phase 4
Details
Lead Sponsor:
Elliot Frohman University of Colorado, Denver
Collaborators:
Mallinckrodt University of Colorado, Denver University of Pennsylvania