NCT00407082已完成2 期
A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Recurrence of uveitis before and after implantation.
研究概览
简要总结
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent, non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study, and had 'quiet' eyes at surgery
排除标准
- •Coexisting medical or ocular conditions that would interfere with the study results
研究组 & 干预措施
Fluocinolone acetonide 0.59mg
Experimental
Fluocinolone acetonide ocular implant 0.59mg
干预措施: fluocinolone acetonide intravitreal implant (Drug)
Fluocinolone acetonide 2.1mg
Experimental
Fluocinolone acetonide ocular implant 2.1mg
干预措施: Fluocinolone acetonide 2.1mg (Drug)
结局指标
主要结局
Recurrence of uveitis before and after implantation.
时间窗: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation
次要结局
- Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.(34 weeks, 1 year, 2 years and 3 years post-implantation)
- Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes.(34 weeks, 1 year, 2 years and 3 years post-implantation)
- The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation)(34 weeks, 1 year, 2 years and 3 years post-implantation)
- Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes)(34 weeks, 1 year, 2 years and 3 years post-implantation)
- Results of QOL surveys pre- versus post-implantation(34 weeks, 1 year, 2 years and 3 years post-implantation)
- Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes)(34 weeks, 1 year, 2 years and 3 years post-implantation)
- Time to recurrence, between treatment group comparison(34 weeks, 1 year, 2 years and 3 years post-implantation)
- Post implantation uveitis rate, between treatment group comparison(34 weeks, 1 year, 2 years and 3 years post-implantation)
研究者
研究点 (1)
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