Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Eyes With Inflammation Recurrence
研究概览
简要总结
The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.
详细描述
Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant.
Hypothesis
The RetisertTM will be a safe and effective method to manage patients with severe uveitis
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-infectious intermediate, posterior or panuveitis
- •Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug
排除标准
- •Infectious uveitis
研究组 & 干预措施
0.59 mg Fluocinolone Acetonide implant
0.59 mg Fluocinolone Acetonide implant
干预措施: 0.59 mg Fluocinolone Acetonide implant (Drug)
结局指标
主要结局
Number of Eyes With Inflammation Recurrence
时间窗: 5 years
Number of eyes with inflammation recurrence
次要结局
- Percentage of Eyes With Improvement in Visual Acuity(baseline to 52 weeks)
- Number of Participant's Eye Requiring Adjunctive Therapy(5 years)
- Number of Eyes With Increased Intraocular Pressure(52 weeks)