Phase 3 study of GGS in patients with optic neuritis (ON)

INTERVENTION: Intervention name : Freeze‐Dried Sulfonated Human Normal Immunoglobulin (GGS) Dosage And administration of the intervention : Intravenous drip infusion Control intervention name : Methylprednisolone sodium succinate Dosage And administration of the control intervention : Intravenous drip infusion CONDITION: optic neuritis PRIMARY OUTCOME: Visual acuity SECONDARY OUTCOME: Main secondary endpoints; Efficacy; 1. Critical flicker frequency; 2. Visual field; ; Safety; 1. Adverse events; 2. Clinical laboratory tests; 3. Vital signs INCLUSION CRITERIA: Patients with optic neuritis responding poorly to steroid agents Main Inclusion Criteria 1.Patients with acute‐onset optic neuritis (including recurrence) 2.Patients with contrast MRI images showing enlarged optic nerve and positive contrast findings 3.Patients of following visual conditions, 7 days after the start of steroid pulse therapy (3‐day intravenous drip infusion of 1,000 mg/day of methylprednisolone) ; ‐ the visual acuity (log MAR value) is more than 1.0 (decimal visual acuity of less than 0.1) ‐ and,no improvement of 0.3 or more as compared with visual acuity at the start of the pulse therapy.