A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 239
- 主要终点
- Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.
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 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
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,
- •Had clinically 'quiet' eyes at surgery.
排除标准
- •Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.
研究组 & 干预措施
Fluocinolone Acetonide 0.59mg
Fluocinolone acetonide intravitreal implant 0.59mg
干预措施: Fluocinolone Acetonide 0.59mg (Drug)
Fluocinolone Acetonide 2.1mg
Fluocinolone acetonide intravitreal 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. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.
时间窗: 1 year pre-implantation; 3 years post-implantation
次要结局
- Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys.(1 year pre-implantation; 3 years post-implantation)