NCT01783925已完成不适用
Eylea Post Marketing Surveillance
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,206
- 试验地点
- 1
- 主要终点
- Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)
研究概览
简要总结
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients determined to start EYLEA treatment
- •Patients who agree and sign informed consent
- •Patients who receive EYLEA treatment for the first time
- •Patients who meet one of the following
- •Patients diagnosed by physician as having neovascular (wet) age-related macular degeneration wAMD
- •Patients diagnosed by physician as having visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO)
- •Patients diagnosed as having visual impairment due to diabetic macular edema (DME)
- •Patients diagnosed as having visual impairment due to myopic choroidal neovascularization (mCNV)
排除标准
- •Patients who have received anti-VEGF therapy within 90 days
- •Patients who are contraindicated based on the approved product label
- •Ocular or periocular infection
- •Active severe intraocular inflammation
- •Known hypersensitivity to any ingredient of this drug
研究组 & 干预措施
Group 1
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)
时间窗: 4 months
次要结局
- Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity](4 months or 8 months)
- Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)(8 months)
- Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography](4 months or 8 months)
- Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography](4 months or 8 months)
- IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure](4 months or 8 months)
- Measurement of fundus lesion by fundoscopy(4 months or 8 months)
研究者
研究点 (1)
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