REFLECTION-An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in Neovascular Age-related Macular Degeneration (nAMD) in a Real-world Setting.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 27
研究概览
简要总结
The goal of this observational study is to explore the effectiveness of aflibercept 8 mg in treating both treatment-naive and previously treated patients with neovascular age-related macular degeneration (nAMD) in a real-world setting. The main questions it aims to answer are:
What are the short-term and long-term efficacy outcomes of aflibercept 8 mg in treatment-naive or previously treated nAMD patients? What are the safety characteristics and the treatment patterns of aflibercept 8 mg in these patient populations?
Participants will:
Receive aflibercept 8 mg as part of their clinical treatment for nAMD. Undergo assessments to evaluate both the efficacy and safety of the treatment over the short and long term.
Provide data on their visual acuity (BCVA) changes at multiple follow-up points (4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months).
Report any adverse events and treatment patterns during the study period. Have their central subfield thickness (CST) measured at specified intervals. This study will help inform clinical practices regarding the use of aflibercept in nAMD patients and contribute to understanding its effectiveness and safety in real-world settings.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥50 years
- •A diagnosis of nAMD
- •Signed informed patient consent before the start of data collection
- •Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice
排除标准
- •Participation in an investigational program with interventions outside of clinical routine practice
- •Contraindications as listed in the intravitreal aflibercept 8 mg local product information (Ocular or periocular infections, severe active intraocular inflammation, and known allergy to aflibercept or any of its excipients)
- •The fellow eye has received intravitreal anti-VEGF treatment other than aflibercept within 28 days prior to enrollment
- •Intraocular pressure (IOP) in the study eye > 25 mmHg
- •Additional exclusion criteria for naïve nAMD patients:
- •Any prior ocular treatment in the study eye or systemic treatment for nAMD
- •Additional exclusion criteria for pretreated nAMD patients:
- •Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days
- •Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months
- •Dexamethasone implant in the study eye within the last 6 months
- •Any concurrent drug releasing implant in the study eye
研究者
Mingwei Zhao
Director of the Department of Ophthalmology at Peking University People's Hospital
Peking University People's Hospital