NCT02080091终止不适用
ILUMINATE: An Open-Label, Non-Interventional Study of the Safety and Effect of Iluvien® (Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Applicator) in Patients With Chronic Diabetic Macular Edema (DME) Insufficiently Responsive to Available Therapies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 主要终点
- Number of Patients With Ocular Adverse Events
研究概览
简要总结
This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients of both sexes that have signed informed consent after detailed information about the characteristics of the observation by the physician
- •DME based on physician's clinical evaluation and demonstrated on fundus photographs and/or optical coherence tomography (OCT);
- •Vision impairment associated with DME
- •Prior treatment with available therapies for DME; and
- •Patients considered by the physician insufficiently responsive to available therapies
排除标准
- •Patients with contraindications according to the current Summary of Product Characteristics (SPC)
- •The presence of pre-existing glaucoma
- •Active or suspected ocular or periocular infection
- •The patient is hypersensitive to the active agent or to one of the excipients
- •Elevated IOP
- •Pregnancy or breastfeeding
结局指标
主要结局
Number of Patients With Ocular Adverse Events
时间窗: 24 Months
Visual Acuity
时间窗: 24 Months
Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.
次要结局
- Retinal Center Subfield Thickness(24 months)
研究者
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