Effectiveness of Plasma Exchange in Treating With Severe Acute AQP4-Ab Positive Optic Neuritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Visual Acuity (LogMAR)
研究概览
简要总结
Patients aged between 18 and 70 with acute aquaporin-4 immunoglobulin G antibodies (AQP4-IgG) positive optic neuritis, irrespective of prior using of corticosteroids in this episode of disease, are chosen by the physician. Patients will then be randomized to receive high dose of intravenous corticosteroids combined with plasma exchange (PE), or merely high dose of intravenous corticosteroids followed subsequent taper. The main outcome of visual acuity and OCT parameters will be compared at baseline, one, three and six months after treatments, and other assessments will also be recorded and compared. This will allow for determination on whether additional PE plays a role in better prognosis in acute AQP4-IgG positive optic neuritis.
详细描述
Definition:
This will be a parallel designed, open-labeled, randomized add-on comparison study between 1) intravenous high dose corticosteroids combined with plasma exchange (PE) and 2) merely intravenous high dose corticosteroids followed subsequent taper of the improvement of optic nerve function in acute aquaporin-4 immunoglobulin G antibodies (AQP4-IgG) positive optic neuritis. The investigators will compare assessments at baseline with those at one, three and six months post treatments.
Patients:
Subjects will be recruited from in-patients who were diagnosed as AQP4-IgG positive optic neuritis in Neuro-Ophthalmology Department in People's Liberation of Army General Hospital (PLAGH) in Beijing, China.
Eligible participants should have inaugural or recurrent unilateral or bilateral optic neuritis attack(s) within 30 days from the first symptom onset. Only affected eyes with VA less than 20/200 at baseline will be included in the study. All of the participants have to have positive serum AQP4-IgG. Enrollment will be allowed irrespective of whether a previous diagnosis of neuromyelitis optica spectrum disorders (NMOSD) was made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome Assessor was masked to avoid measured bias
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 70 years old
- •Serum AQP4-IgG positive optic neuritis
- •Patients must have their VA less than 20/200
- •Course of disease is less than 1 month
- •Patients must provide written informed consent
排除标准
- •Females who are pregnancy
- •Patients who are severely allergic to plasma or albumin
- •Patients who have systemic disease and can not accept PE
- •Patients with a tendency to thrombus
研究组 & 干预措施
Corticosteroid & Plasma Exchange
1000mg intravenous methylprednisolone daily for 3~5 days and subsequent taper, combined with plasma exchange every other day for five times in all
干预措施: Corticosteroid & Plasma exchange (Device)
Corticosteroid
1000mg intravenous methylprednisolone daily for 3~5 days, and subsequent corticosteroid decrement.
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Visual Acuity (LogMAR)
时间窗: from baseline to 6 months
the differences in Visual Acuity outcomes between treatment arm and control arm
Change in OCT parameters over time
时间窗: baseline to 6 months
Difference in mean thickness of peripapillary retinal nerve fiber layer and macular Ganglion Cell Complex between treatment group and control group
次要结局
- change in serum AQP4-IgG titer over time(baseline to 6 months)
- orbital MRI(baseline to 6 months)
- Change in Flash Visual Evoked Potential over time(baseline to 6 month)
- rate of recurrence over time(baseline to 6 months)
研究者
Wei Shihui
Professor of Neuro-Ophthalmology
Chinese PLA General Hospital