NCT02424019已完成4 期
A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 41
- 主要终点
- Intraocular Pressure
研究概览
简要总结
This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.
详细描述
The specific objectives include the study of intraocular pressure (IOP) related data in patients who received ILUVIEN and how it relates to the patient's experiences following prior treatment with a course of corticosteroid which did not result in a clinically significant IOP elevation.
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
- •Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.
排除标准
- •Patients who are unable to understand and sign the Informed Consent Form.
研究组 & 干预措施
ILUVIEN 0.19 MG
Experimental
All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
干预措施: ILUVIEN 0.19 MG (Drug)
结局指标
主要结局
Intraocular Pressure
时间窗: 36 months
Intraocular pressure of the ILUVIEN treated eye
次要结局
未报告次要终点
研究者
研究点 (41)
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