NCT01998412Unknown不适用
An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 559
- 主要终点
- Number of participants with adverse events.
研究概览
简要总结
The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient treated with Iluvien under this protocol will be included in the study.
排除标准
- •Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study.
- •Retrospective Enrollment Criteria
- •Patients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements:
- •The site is allowed to enroll a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit.
- •The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study.
- •The eligible patient must be enrolled at least one year prior to the planned end of the study.
结局指标
主要结局
Number of participants with adverse events.
时间窗: 5 years
次要结局
未报告次要终点
研究者
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