Real-world Study of Aflibercept 8 mg in nAMD

Recruiting now

Conditions studied: Neovascular Age-Related Macular Degeneration (nAMD)

In brief

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.

Key facts

Study ID

NCT07640997

Run by

Peking University People's Hospital

People needed

300

Starts

2025-11-11

Expected to finish

2027-12-31

Last updated by the study team

2026-06-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Nanyang Eye Hospital — Nanyang, Henan, China (enrolling)
• Dalian No.3 People's Hospital — Dalian, Liaoning, China (enrolling)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Beijing Haidian Hospital — Beijing, Beijing Municipality, China (enrolling)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
• Shenzhen Eye Hospital — Shenzhen, Guangdong, China
• Affiliated Hospital Of Zunyi Medical University — Zunyi, Guizhou, China
• The 2nd Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• Tongji Hospital Tongji Medical College of HUST — Wuhan, Hubei, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China
• The Fourth People's Hospital Of Shenyang — Shenyang, Liaoning, China
• Xi'an People's Hospital — Xi'an, Shaanxi, China
• Jinan Second People's Hospital — Jinan, Shandong, China
• Qingdao Eye Hospital Of Shandong First Medical University — Qingdao, Shandong, China
• Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China
• TONG REN Hospital, Shanghai Jiao Tong University School Of Medicine — Shanghai, Shanghai Municipality, China
• Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
• Tianjin Medical University Eye Hospital — Tianjin, Tianjin Municipality, China
• Ningbo Eye Hospital — Ningbo, Zhejiang, China
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
• Beijing CHAO-YANG Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• Peking University First Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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