NCT04207983已完成2 期
A 48 Week Phase II, Randomized, Open-Label, Multicenter, Study to Evaluate the Efficacy and Safety of Two (2) EYS606 Treatment Regimens in Subjects With Active Chronic Non-infectious Uveitis (CNIU)
Eyevensys6 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年2月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 6
- 主要终点
- Time to rescue therapy between the two EYS606 treatment regimens
研究概览
简要总结
The objective of the study is to evaluate the efficacy and safety of two different treatment regimens of EYS606.
详细描述
This is a Phase 2, multi-center, randomized open-label interventional study of EYS606 in subjects with active chronic non-infectious uveitis.
The maximum study duration per patient is 51 Weeks (including an up to 3 week screening period + 48 weeks follow-up after treatment).
The study will be conducted in 2 parts. Part I is a safety cohort phase that will enroll up to 6 subjects, Part II is the randomized comparison phase that will enroll up to an additional 50 subjects.
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
- 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
- •Key Eligibility Criteria:
- •Subject must be 18 years of age or older.
- •Subject must have a diagnosis of chronic non-infectious uveitis of any anatomic subtype (anterior, intermediate, posterior or panuveitis).
- •Subject must have a history of chronic or recurrent non-infectious uveitis requiring or having required treatment with corticosteroids (systemic, periocular or intraocular) and/or systemic immunosuppressive medication(s) in the 12 months prior to the screening visit.
- •Best corrected visual acuity of
- •Study Part I: ≥ 5 and < 67 ETDRS letters in the study eye (equivalent to less than or equal to 20/50 but better than or equal to 20/800 Snellen).
- •Study Part II: ≥ 5 and < 77 ETDRS letters in the study eye (equivalent to less than or equal to 20/32 but better than or equal to 20/800 Snellen).
- •At the screening and baseline visits subject must have active chronic non-infectious uveitis as evidenced by at least one or more of the following in the study eye:
- •Active retinal vasculitis (retinal vascular leakage) involving the posterior pole confirmed by the reading center.
- •Vitreous haze grade ≥ 2+ (SUN classification).
- •Anterior chamber cell grade ≥ 2+ (SUN classification); anterior chamber cells must be present for subjects with a diagnosis of chronic anterior non-infectious uveitis.
- •Persistent macular edema (defined as central retinal thickness (CRT) > 300 microns or > 320 microns using Zeiss Cirrus and Topcon or Heidelberg Spectralis spectral domain ocular coherence tomography (SD-OCT) instruments, respectively) despite treatment with corticosteroids and/or immunosuppressive therapy for at least 4 weeks prior to screening.
- •Subject receiving concomitant topical and/or systemic corticosteroids or allowed systemic immunosuppressive medications must have maintained the same treatment regimen (dosage/frequency) for at least 2 weeks prior to the baseline (V1) visit, (if applicable).
排除标准
- 未提供
结局指标
主要结局
Time to rescue therapy between the two EYS606 treatment regimens
时间窗: Week 24
Assessment of efficacy measured as time to rescue therapy required after treatment with EYS606
次要结局
- Median time to control of active CNIU(Each Visit up to Week 48)
- Median time to loss of treatment effect(Each Visit up to Week 48)
- Proportion (%) of subjects responded to the treatment(Week 8 and 24)
- Median change in visual acuity(Each Visit up to Week 48)
- Proportion (%) of subjects achieving and maintaining active chronic noninfectious posterior uveitis (CNIU)(Week 24)
研究者
研究点 (6)
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