recurrent optic neuritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria of optic neuritis as defined by ONTT, and the serum AQP4-Ab or MOG-Ab was positive by CBA assay; 2.Patients with recurrent ON (recurrence was defined as visual loss at least 2 lines as measured by standard logarithmic acuity chart after standardized use of AZA/MMF/RTX, and supported by imaging evidence: enhanced in orbital MRI); 3.18 years old <= age <= 65 years old; 4.No gender limitation; 5.Willing to comply with the test program, and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Those who are allergic to any ingredient in the test drug; 3.Patients with severe cardiovascular, liver, kidney or hematopoietic diseases, diabetes, and blood pressure >= 140/90 mmHg; 4.There is a history of using other DMT drugs in the past six months: such as interferon, natalizumab, FTY-720, etc.; 5.Those who have participated in clinical trials of other new drugs in the last 3 months; 6.Those who cannot complete the research according to the clinical trial protocol due to severe mental or language barriers; 7.The investigator believes that it is not suitable to participate in this clinical trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interval of disease recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity changes;The changes of retinal optic nerve fiber layer thickness;The changes of ganglion cells in macular area;Variation of visual field; | — |
Countries
China
Contacts
PLA General Hospital