European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Incidence of POAEs Per Injection Reported by Gender (Females)
研究概览
简要总结
The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.
详细描述
No comparator Patients with age-related macular degeneration
研究设计
- 研究类型
- Observational
- 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
- •Neovascular AMD patients who are eligible for Macugen therapy based on the approved label
排除标准
- •Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.
研究组 & 干预措施
Observational study, no comparator
Observational study of patients with AMD treated with Macugen, no comparator
干预措施: Macugen (Drug)
结局指标
主要结局
Incidence of POAEs Per Injection Reported by Gender (Females)
时间窗: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection
时间窗: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received.
次要结局
- Incidence of POAEs Per Injection Reported by Gender (Males)(Baseline up to 2 years)
- Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)(Baseline up to 2 years)
- Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)(Baseline up to 2 years)
- Number of Participants With Serious Hypersensitivity Reactions(Baseline up to 2 years)
- Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)(Baseline up to 2 years)
- Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)(Baseline up to 2 years)