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
Neuro-Eye Clinical Trials
Houston, Texas, United States
RECRUITINGProportion 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 LCVA.
Time frame: 3 months
Mean change from baseline in 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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