Optic Neuritis of Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder
Conditions
Interventions
Observation Group of Neuromyelitis optica Spectrum Disorders:None
Sponsors
Henan Provincial Eye Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: For retrospective cohorts, the following inclusion criteria were followed: 1. Age at onset >=12 years old; 2. Serological tests at the onset of the disease confirmed positive AQP4 antibodies, which was in line with the diagnosis of NMOSD. 3. The clinical symptoms at the onset of the disease are in line with the typical manifestations of demyelinating optic neuritis, and satrizumab is initiated in the early stage of optic neuritis (within 2 weeks of the first attack or within 2 weeks of recurrence). 4. At the onset of the disease, orbital MRI examination showed that the optic nerve of the participants was thickened, strengthened or normal, but there were no space-occupying lesions in the orbit or sellar region. 5. At the time of enrollment, sign the informed consent form (for those under 18 years old, participants sign the juvenile version of the informed consent form) and be willing to abide by the requirements of the research protocol. For prospective cohorts, the following inclusion criteria were followed: 1. Age >=12 years old; Serological testing confirmed a positive AQP4 antibody, which is in line with the diagnosis of NMOSD. 3. During the acute attack period of optic neuritis, the clinical symptoms are in line with the typical manifestations of demyelinating optic neuritis, and satrizumab treatment is initiated in the early stage of optic neuritis attack (within 2 weeks of the first attack or within 2 weeks of recurrence). 4. Orbital MRI examination shows that the optic nerve on the affected side is thickened, strengthened or normal, but there are no space-occupying lesions in the orbit or sellar region. 5. Sign the informed consent form (for those under 18 years old, participants sign the juvenile version of the informed consent form) and be willing to comply with the requirements of the research protocol.
Exclusion criteria
Exclusion criteria: For retrospective cohorts, the following exclusion criteria were followed: 1. Other eye diseases that may affect visual function or fundus examination and assessment: such as severe cataracts, glaucoma, high myopia, or hereditary or toxic optic neuropathy, etc. 2. Being in a critical illness state or having any mental or cognitive disorders that may interfere with the research, and being unable to complete the key assessment required by this protocol; 3. Known allergy to satrizumab or any inactive ingredients, active hepatitis B or C, active or untreated tuberculosis, combined with severe infection, HIV, syphilis, etc. 4. Those who received inalizumab/rituximab within 6 months before enrollment, ecucuzumab within 2 weeks before enrollment, or other biological agents that were evaluated by the investigators as unsuitable for enrollment before enrollment. For prospective cohorts, the following exclusion criteria are followed: 1. Other eye diseases that may affect visual function or fundus examination and assessment: such as severe cataracts, glaucoma, high myopia, or hereditary or toxic optic neuropathy, etc. 2. Being in a critical illness state or having any mental or cognitive disorders that may interfere with the research, and being unable to complete the key assessment required by this protocol; 3. Known allergy to satrizumab or any inactive ingredients, active hepatitis B or C, active or untreated tuberculosis, combined with severe infection, HIV, syphilis, etc. 4. Those who received inalizumab/rituximab within 6 months before enrollment, ecucuzumab within 2 weeks before enrollment, or other biological agents that were evaluated by the investigators as unsuitable for enrollment before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-Corrected Visual Acuity(BCVA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Defect Value(MD Value);Retinal Nerve Fiber Layer Thickness (RNFL);Ganglion Cell Complex Thickness (GCC); | — |
Countries
China
Contacts
Public ContactHongpei Cui
Henan Provincial Eye Hospital;Henan Provincial People's Hospital
Outcome results
None listed