NCT00404742已完成3 期
A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
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
- 232
- 试验地点
- 40
- 主要终点
- recurrence of ocular inflammation
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious 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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis.
- •Minimum prescribed therapy upon enrollment is one or more of the following:
- •systemic prednisone or equivalent averaging ≥ 10 mg/day
- •at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization).
- •at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate
- •Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks
- •Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR <1.34)
- •Subjects not planning to undergo elective ocular surgery during the study
排除标准
- •Evidence of active, uncontrolled non-infectious uveitis
- •Periocular administration of corticosteroids within the previous 6 weeks.
- •Uveitis of infectious etiology
- •Uncontrolled glaucoma
- •Clinically suspected or confirmed central nervous system or ocular lymphoma
- •History or diagnosis of Behçet's disease
- •Primary diagnosis of anterior uveitis
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
LX211, 0.2 mg/kg
Active Comparator
干预措施: LX211 (Drug)
LX211, 0.4 mg/kg
Active Comparator
干预措施: LX211 (Drug)
LX211, 0.6 mg/kg
Active Comparator
干预措施: LX211 (Drug)
结局指标
主要结局
recurrence of ocular inflammation
时间窗: 26 weeks
次要结局
- BCVA(26 weeks)
- systemic corticosteroid usage(26 weeks)
研究者
研究点 (40)
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