The goal of this clinical trial is to evaluate the safety and efficacy of privosegtor, a neuroprotective candidate, in patients diagnosed with optic neuritis (ON). Researchers will compare privosegtor and the standard of care (methylprednisolone) to a placebo and standard of care (methylprednisolone).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days
Methylprednisolone 1 g/day IV for 5 treatment days
0.9% sodium chloride (NaCl) solution IV for 5 treatment days
Kahana Oculoplastic and Orbital Surgery
Livonia, Michigan, United States
RECRUITINGMedical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, United States
RECRUITINGUT Southwestern Medical Center (Ophthalmology CRU)
Dallas, Texas, United States
Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA).
Time frame: 3 months
Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA).
Time frame: 3 months
Mean change from baseline in low contrast visual acuity (LCVA).
Time frame: 3 months
Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness.
Time frame: 3 months
Serum neurofilament light chain (sNfL) mean change from baseline.
Time frame: Through month 3
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Neuro-Eye Clinical Trials
Houston, Texas, United States
RECRUITING