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Real-world Study of Aflibercept 8 mg in nAMD

2026年6月10日 更新者：Mingwei Zhao、Peking University People's Hospital

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.

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 尚未招聘
        • Peking University First Hospital
        • 接触：
      • Beijing、Beijing Municipality、中国
        • 尚未招聘
        • Peking University Third Hospital
        • 接触：
      • Beijing、Beijing Municipality、中国、100044
        • 招聘中
        • Peking University People's Hospital
        • 接触：
      • Beijing、Beijing Municipality、中国
        • 招聘中
        • Beijing Friendship hospital, Capital Medical University
        • 接触：
      • Beijing、Beijing Municipality、中国
        • 尚未招聘
        • Peking Union Medical College Hospital
        • 接触：
          • Weihong Yu
          • 电话号码：+86-13671214306
          • 邮箱：yuwh@pumh.cn
      • Beijing、Beijing Municipality、中国
        • 尚未招聘
        • Beijing Chao-Yang Hospital, Capital Medical University
        • 接触：
      • Beijing、Beijing Municipality、中国
        • 招聘中
        • Beijing Haidian Hospital
        • 接触：
    • Fujian
      • Fuzhou、Fujian、中国
        • 尚未招聘
        • The First Affiliated Hospital of Fujian Medical University
        • 接触：
          • Jian Guo
          • 电话号码：+86-13799395637
    • Guangdong
      • Shenzhen、Guangdong、中国
        • 尚未招聘
        • Shenzhen Eye Hospital
        • 接触：
    • Guizhou
      • Zunyi、Guizhou、中国
        • 尚未招聘
        • Affiliated Hospital of Zunyi Medical University
        • 接触：
    • Heilongjiang
      • Harbin、Heilongjiang、中国
        • 尚未招聘
        • The 2nd Affiliated Hospital of Harbin Medical University
        • 接触：
    • Henan
      • Nanyang、Henan、中国
        • 招聘中
        • Nanyang Eye Hospital
        • 接触：
          • Yinwei Li
          • 电话号码：+86-18537366615
    • Hubei
      • Wuhan、Hubei、中国
        • 尚未招聘
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 接触：
      • Wuhan、Hubei、中国
        • 尚未招聘
        • Tongji Hospital Tongji Medical College Of Hust
        • 接触：
    • Inner Mongolia
      • Hohhot、Inner Mongolia、中国
        • 尚未招聘
        • The Affiliated Hospital of Inner Mongolia Medical University
        • 接触：
    • Liaoning
      • Dalian、Liaoning、中国
        • 招聘中
        • Dalian No.3 People's Hospital
        • 接触：
      • Shenyang、Liaoning、中国
        • 尚未招聘
        • The Fourth People's Hospital of Shenyang
        • 接触：
    • Shaanxi
      • Xi'an、Shaanxi、中国
        • 尚未招聘
        • Xi'an People's Hospital
        • 接触：
    • Shandong
      • Jinan、Shandong、中国
        • 尚未招聘
        • Jinan Second People's Hospital
        • 接触：
      • Qingdao、Shandong、中国
        • 尚未招聘
        • Qingdao Eye Hospital of Shandong First Medical University
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国
        • 尚未招聘
        • Shanghai Tenth People's Hospital
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • 尚未招聘
        • TONG REN Hospital, Shanghai Jiao Tong University School Of Medicine
        • 接触：
          • Qinghua Qiu
          • 电话号码：+86-13386259756
    • Sichuan
      • Chengdu、Sichuan、中国
        • 尚未招聘
        • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
        • 接触：
          • Jie Zhong
          • 电话号码：+86-13808063276
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国
        • 招聘中
        • Tianjin Medical University General Hospital
        • 接触：
      • Tianjin、Tianjin Municipality、中国
        • 尚未招聘
        • Tianjin Medical University Eye Hospital
        • 接触：
    • Zhejiang
      • Ningbo、Zhejiang、中国
        • 尚未招聘
        • Ningbo Eye Hospital
        • 接触：
      • Wenzhou、Zhejiang、中国
        • 尚未招聘
        • The First Affiliated Hospital of Wenzhou Medical University
        • 接触：
          • Zipei Jiang
          • 电话号码：+86-13857795272

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients will be enrolled in eye clinics or ophthalmology practices

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
naïve nAMD
200 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up.
药品：Aflibercept 8mg
Aflibercept 8mg, following the manner of observational study, no intervention will be provided in the study. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and follows approved clinical guidelines.
pretreated nAMD
100 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up.
药品：Aflibercept 8mg
Aflibercept 8mg, following the manner of observational study, no intervention will be provided in the study. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and follows approved clinical guidelines.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The change of best corrected visual acuity (BCVA) from baseline to 12 months（BCVA will be examined under real-world conditions and converted into ETDRS letters. ）
大体时间：Baseline to Month 12
Baseline to Month 12

次要结果测量

结果测量
大体时间
The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months as evaluated in routine clinical practice
大体时间：Baseline to Month 12
Baseline to Month 12
The change of central subfield thickness(CST) from baseline to 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months as evaluated in routine clinical practice
大体时间：Baseline to Month 12
Baseline to Month 12
Number of aflibercept 8 mg injections in the study eye during the first 6 months and 12 months
大体时间：Baseline to Month 12
Baseline to Month 12
Number of visits regarding the study eye by type of visit during the 6 months and 12 months treatment period
大体时间：Baseline to Month 12
Baseline to Month 12
The proportion of study eyes for each treatment regimen (fixed regimen, treatment-extension regimen, as-needed regimen, or other regimens) from baseline to 6 months and 12 months.
大体时间：Baseline to Month 12
Baseline to Month 12
The proportion of study eyes for the distribution of the last treatment interval from baseline to 6 months and 12 months.
大体时间：Baseline to Month 12
Baseline to Month 12
The number of patients who experienced (serious) adverse events and (serious) drug-related adverse events from the baseline to 12 months thereafter.
大体时间：Baseline to Month 12
Baseline to Month 12
Percentage of eyes without IRF and/or SRF in the central macular area at 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months after the 8 mg injection of Aflibercept compared to before the injection.
大体时间：Baseline to Month 12
Baseline to Month 12
Percentage of eyes with regression/or improvement of PED at 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months after the 8 mg injection of Aflibercept compared to before the injection.
大体时间：Baseline to Month 12
Baseline to Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking University People's Hospital

合作者

Bayer

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月11日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2025年12月8日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 23083

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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