A Multicenter, Open Label Pilot Study to Explore the Efficacy and Safety of Acthar Gel in Subjects With Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis (NIPPU)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mallinckrodt
- 入组人数
- 5
- 试验地点
- 8
- 主要终点
- Score on the Nussenblatt Grading Scale
研究概览
简要总结
The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea.
Also, safety information when using it for this purpose will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Acthar Gel
Participants received Acthar 1 mL (80 units [U]) subcutaneously (SC) 2 times per week for 36 weeks followed by a taper to Acthar 1 mL (80 U) SC once a week for 2 weeks, then 0.5 mL (40 U) SC once a week for 2 weeks.
干预措施: Acthar Gel (Drug)
结局指标
主要结局
Score on the Nussenblatt Grading Scale
时间窗: Week 36
The Nussenblatt grading scale uses photographic measurement of cloudy, declining vision (vitreous haze). The scale goes from 0 to 4, and lower scores are better.
Score on the Laser Flare Scale
时间窗: Week 36
Protein that escapes from blood vessels inside the eye make a sudden burst of scattered light (flare) when a laser shines on them. This is called a laser flare. It is used to measure the amount and size of proteins in the clear fluid in the front of the eyeball (aqueous humour). The larger the flare, the more inflammation is inside the eye (intraocular inflammation) in patients with uveitis. Laser flare is scored on a scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Lower scores are better.
Score on the Aqueous Cell Scale
时间窗: Week 36
The number of cells (like white blood cells) floating in the aqueous humour (aqueous cells) are measured on a scale from 0 (none) to 4 (more than 30 cells), and lower scores are better.
次要结局
- Diurnal Intraocular Pressure (IOP)(Week 36)