Find Age-Related Macular Degeneration (ARMD) Clinical Trials Near You
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.
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing CHAO-YANG Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Haidian Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Dalian No.3 People's Hospital
RECRUITING
Dalian
The First Affiliated Hospital Of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
The 2nd Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Jinan Second People's Hospital
NOT_YET_RECRUITING
Jinan
Nanyang Eye Hospital
RECRUITING
Nanyang
Ningbo Eye Hospital
NOT_YET_RECRUITING
Ningbo
Qingdao Eye Hospital Of Shandong First Medical University
NOT_YET_RECRUITING
Qingdao
Shanghai Tenth People's Hospital
NOT_YET_RECRUITING
Shanghai
TONG REN Hospital, Shanghai Jiao Tong University School Of Medicine
NOT_YET_RECRUITING
Shanghai
The Fourth People's Hospital Of Shenyang
NOT_YET_RECRUITING
Shenyang
Shenzhen Eye Hospital
NOT_YET_RECRUITING
Shenzhen
Tianjin Medical University Eye Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University General Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Tongji Hospital Tongji Medical College of HUST
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Xi'an People's Hospital
NOT_YET_RECRUITING
Xi'an
Affiliated Hospital Of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Mingwei Zhao
dr_zhaomingwei@163.com
+86 13801057408
Time Frame
Start Date:2025-11-11
Estimated Completion Date:2027-12-31
Participants
Target number of participants:300
Treatments
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.
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.