Structured Post-marketing Surveillance to Collect the Safety Data of Intravitreal Aflibercept Injection (IVT-AFL) in Patients of Wet Age-related Macular Degeneration During Real World Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of reported ocular and non-ocular adverse events during observation period
研究概览
简要总结
The proposed regulatory post-marketing surveillance (PMS) study will be planned to collect the safety data of aflibercept intravitreal injection in patients with wet Age-related Macular Degeneration (AMD) in real-life treatment practice
The primary objective is:
- To collect safety data in wet AMD patients treated with intravitreal aflibercept injection
The secondary objective is:
- To determine how disease activity is monitored including type and frequency of ocular tests and frequency of injections
详细描述
The study will be multicenter, observational, prospective, single arm, post marketing surveillance study of intravitreal aflibercept injection in wet AMD patients in routine clinical practice and real-life conditions without any protocol mandated interventions.
Approximately 100 wet AMD patients from up to ten ophthalmology clinics across India will be enrolled in this study. Each study site will be requested to enroll approximately 10 patients, however, the sites will be asked to enrolled additional patients in case of failure to enroll 10 patients by other site to complete the recruitment of approximately 100 patients.
Patients will be observed for maximum period of 6 months after the start of intravitreal aflibercept treatment. The observation period should cover the entire period from initial visit to the last follow-up visit at six months or withdrawal of consent, or the patient is lost to follow up (whatever is earliest).
The study site will be asked to enroll into the study all consecutive patients with wet AMD for whom the decision has been made to treat with intravitreal aflibercept injection and patients agrees to sign informed consent form for data collection purpose.
Any switch to another therapy or initiated administration of other anti-VEGF (Vascular Endothelial Growth Factor) injection in fellow eye or the discontinuation of treatment with IVT-AFL before the 6 month implies the end of the observation period. However, the safety follow-up will continue at least 30 days after last intravitreal aflibercept injection or in case of the discontinuation of treatment with IVT-AFL or till the patient switch the treatment from IVT-AFL and received other anti-VEGF injection before the 6 month observation period.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Decision to treat with intravitreal aflibercept injection prior to patient enrolment as per the treating ophthalmologist's routine clinical practice.
- •Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities (DCGI) for use with intravitreal aflibercept injection.
- •Patient or legal delegate signed informed consent.
排除标准
- •Participation in a clinical trial of an investigational agent within 30 days.
- •Patients receiving other anti-VEGF agent in fellow eye.
- •Contraindications according to the local prescribing information.
研究组 & 干预措施
Decision to treat with intravitreal aflibercept for wet AMD
Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept.
干预措施: Aflibercept (Eylea, BAY86-5321) (Drug)
结局指标
主要结局
Frequency of reported ocular and non-ocular adverse events during observation period
时间窗: Up to 6 months
unilateral / bilateral treatment
Percentage of reported ocular and non-ocular adverse events during observation period
时间窗: Up to 6 months
unilateral / bilateral treatment
次要结局
- Date of aflibercept injections(Up to 6 months)
- Injection dose(Up to 6 months)
- Interval (days) between aflibercept injections(Up to 6 months)
- Frequency of monitoring / clinic visits(Up to 6 months)
- Type of ocular tests undertaken(Up to 6 months)
- Interval between ocular test(Up to 6 months)