NCT01243983已完成3 期
A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
- 主要终点
- The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier.
研究概览
简要总结
The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Active noninfectious uveitis involving the intermediate and/or posterior segment (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified.
- •Subjects must be:
- •Capable of understanding the purpose and risks of the study.
- •Able to give written informed consent.
- •Able to comply with all study requirements.
排除标准
- •Ocular Disease/Conditions
- •The following conditions are exclusionary if present:
- •Uveitis limited to only the anterior segment of the study eye.
- •Confirmed or suspected infectious uveitis in either eye.
- •Prior and Current Treatment:
- •As defined in the protocol
- •Extraocular Conditions:
- •As defined in the protocol.
- •Laboratory, Blood Pressure and ECG Evaluations:
- •As defined in the protocol.
研究组 & 干预措施
LX211
Experimental
干预措施: LX211 (Drug)
Placebo
Placebo Comparator
干预措施: LX211 (Drug)
结局指标
主要结局
The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier.
时间窗: 12 weeks
次要结局
- Daily mean systemic corticosteroid dose used during Weeks 12-24(Weeks 12-24)
- Time to augmentation with corticosteroid therapy.(Week 24)
研究者
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