Isolated aquaporin4 antibody seropositive optic neuritis
Conditions
Interventions
Evaluation of the efficacy and safety of Inebilizumab therapy for acute-phased, isolated AQP-4 Ab positive optic neuritis:30 cases with acute-phased, isolated AQP-4 Ab positive optic neuritis are ass
Evaluation of the efficacy and safety of Inebilizumab therapy for remission-phased, isolated AQP-4 Ab positive optic neuritis:30 cases with remission-phased, isolated AQP-4 Ab positive optic neuritis
Sponsors
Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: AQP-4Ab-positive isolated optic neuritis 18 years of age and older, male or female, acute or in remission. a. Ophthalmologic clinical manifestations consistent with the typical findings of demyelinating optic neuritis; b. Serologic testing (cell-based dual indirect immunofluorescence assay) confirming positive AQP-4Ab; c. Orbital MRI shows thickened, enhanced, or normal optic nerve on the affected side, but no orbital or sellar mass lesions; d. Signed informed consent and willing to comply with study protocol requirements.
Exclusion criteria
Exclusion criteria: a. The patient is accompanied by other eye diseases which may affect visual function evaluation or fundus examination, such as severe cataracts, glaucoma, high myopia, or hereditary or toxic optic neuropathy; b. Pregnant or lactating women, or those planning to conceive during the study period; c. Combining severe infections, other serious systemic diseases, or malignant tumors; d. Combining infectious diseases such as active hepatitis B, hepatitis C, HIV, syphilis, or active tuberculosis; e. Prior to enrollment, received the following medicationtherapy: IL-6 receptor inhibitors (such as tocilizumab, satolizumab, etc.); within 6 months prior to enrollment, received rituximab therapy, or other investigational drug therapy. Laboratory exclusion criteria: routine blood test shows white blood cell count<3.0 × 10 ^ 9/L; immune cell count shows lymphocyte number <0.5 × 10 ^ 9/L; liver function test showed the value of alanine aminotransferase or aspartate aminotransferase is greater than 1.5 times the upper limit of its normal value.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate of optic neuritis;Best corrected visual acuity;Visual functions score of the Expanded Disability Status Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual recurrence rate of optic neuritis;Mean sensitivity of visual field test;Mean defect of visual field test; | — |
Countries
China
Contacts
Public ContactSun Chuanbin
Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed