optic neuritis
Conditions
Sponsors
Teijin Pharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria 1. Patients with a history of shock or hypersensitivity to any component of the investigational product 2. Patients with serious infection complicated by impaired renal function or chronic renal failure 3. Patients with acute myocardial infarction 4. Patients with IgA deficiency 5. Patients with hemolytic/blood loss anemia 6. Patients with reduced cardiac function 7. Patients with cerebrovascular or cardiovascular disorder 8. Patients with a high risk of thromboembolism 9. Patients with immunodeficiency or under immunosuppression 10. Pregnant, potentially pregnant, or lactating patients 11. Patients who are being treated in other clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Primary endpoint: Visual acuity Evaluation method: Visual acuity test | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Main secondary endpoints Efficacy 1. Critical flicker frequency 2. Visual field Safety 1. Adverse events 2. Clinical laboratory tests 3. Vital signs Evaluation method Critical flicker frequency test, Visual field test | — |
Countries
Japan
Outcome results
None listed