NCT00803816已完成2 期
Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
Carsten Heinz1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Inactivity of uveitis
研究概览
简要总结
Study efficacy of everolimus on course of uveitis:
- obtain quiescence of inflammation after start of treatment
- duration to obtain quiescence of inflammation
- number of patients with quiescence of inflammation
详细描述
occurence of new complications from uveitis
- course of visual acuity (LogMAR): percentage of patients with visual loss of 10 or more numbers on ETDRS as compared to baseline
- change of recurrence rate as compared to time before everolimus treatment
- occurence of recurrence after obtaining remission with everolimus treatment
- duration to occurence of recurrence o number of patients with recurrence
- corticosparing effect from everolimus
- number of patients without topical corticosteroids; number of patients with reduced topical corticosteroids (<3x/daily)
- number of patients without systemic corticosteroids; number of patients with reduced systemic corticosteroids (<10mg/daily)
- efficacy of uveitis within 12 months
- maintenance of remission after withdrawel of everolimus treatment at 12 months o course of cystoid macula edema (FLA, OCT)
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
- •endogenous intermediate or posterior uveitis
- •no quiesence in previous 3 months under systemic and topical steroids or systemic cyclosporine A
- •indication for steroid sparing therapy
- •uveitis related vision threating complications
- •negative pregnancy test
- •effective contraception
排除标准
- •Ophthalmic parameters:
- •silicone oil in anterior chamber of both eyes para- or intraocular corticosteroid injections within previous 8 weeks
- •opacities of optic media that obscure visualization of anterior or posterior eye segments
- •General parameters:
- •requirement for combined immunosuppression for systemic immune-mediated disease contraindication against everolimus or cyclosporine A
- •positive tuberculine test (GT 10
- •currently immunosuppressive therapy with immunosuppressive drug other than cyclosporine
- •poor compliance
- •known intolerance to medication
研究组 & 干预措施
Addition of everolimus to standard care
Other
refractive to cyclosporine A (CsA) received additional everolimus.
干预措施: everolimus (Drug)
结局指标
主要结局
Inactivity of uveitis
时间窗: 1 year
次要结局
- Reoccurence of uveitis(2 years)
研究者
Carsten Heinz
Prof Heiligenhaus Head of Department
St. Franziskus Hospital
研究点 (1)
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