Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica (NMO) and Gene Polymorphism

• Conditions: Glucocorticoid Resistance; Gene; Neuromyelitis Optica
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT04601142
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

Aims of this study are to observe the correlation between ABCB1、VDR、TBX21、NR3C1 and other gene polymorphisms and the effect of glucocorticoid shock therapy on neuromyelitis optica. Investigators plan to include patients with neuromyelitis optica who will receive glucocorticoid shock therapy prospectively. The patients are divided into glucocorticoid sensitive (GS) group and glucocorticoid resistance (GR) group according to the change of central vision after treatment. Patients' clinical data will be collected and blood samples are needed for single nucleotide polymorphism (SNP) typing test. Through statistical analysis, the data differences between GS group and GR group were compared, and the effects of clinical indexes and gene polymorphisms on the efficacy of glucocorticoid shock therapy in the treatment of neuromyelitis optica should be analyzed.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Study First Posted: 2020-10-23
• Last Update Posted: 2020-10-23
• Study Start: 2020-10-31
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Clinical diagnosis of neuromyelitis optica
• Chinese Han nationality, gender is unlimited;
• Must be able to accept methylprednisolone pulse therapy

Exclusion Criteria

• Other optic nerve diseases, such as ischemic, compressive, invasive, traumatic, toxic and nutritional metabolic, hereditary optic neuropathy;
• Visual path and central lesion on optic chiasma;
• Other eye diseases, such as anterior segment lesions, retinopathy, macular lesions, ametropia, glaucoma, etc;
• Non-organic visual impairment;
• Treated with glucocorticoid in two weeks.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
glucocorticoid resistance (GR) group	Methylprednisolone	-
glucocorticoid sensitive (GS) group	Methylprednisolone	-

Primary Outcome Measures

Name	Time	Method
the change of best corrected visual acuity (BCVA)	3 day after the treatment of methylprednisolone pulse therapy	Test BCVA before and after the treatment of methylprednisolone pulse therapy, and calculate the change value

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, China