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Clinical Trials in China / NCT07640997
Recruiting Observational

Real-world Study of Aflibercept 8 mg in nAMD

NCT07640997 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Observational
Started
2025-11-11
Last updated
2026-06-11

Condition(s) studied

Neovascular Age-Related Macular Degeneration (nAMD)

Investigational drug(s) / intervention(s)

Aflibercept 8mg

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.

Study 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

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality Recruiting
Beijing CHAO-YANG Hospital, Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Beijing Haidian Hospital Beijing Beijing Municipality Recruiting
Peking Union Medical College Hospital Beijing Beijing Municipality Not Yet Recruiting
Peking University First Hospital Beijing Beijing Municipality Not Yet Recruiting
Peking University Third Hospital Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital Of Fujian Medical University Fuzhou Fujian Not Yet Recruiting
Shenzhen Eye Hospital Shenzhen Guangdong Not Yet Recruiting
Affiliated Hospital Of Zunyi Medical University Zunyi Guizhou Not Yet Recruiting
The 2nd Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Not Yet Recruiting
Nanyang Eye Hospital Nanyang Henan Recruiting
Tongji Hospital Tongji Medical College of HUST Wuhan Hubei Not Yet Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Not Yet Recruiting
The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia Not Yet Recruiting
Dalian No.3 People's Hospital Dalian Liaoning Recruiting
The Fourth People's Hospital Of Shenyang Shenyang Liaoning Not Yet Recruiting
Xi'an People's Hospital Xi'an Shaanxi Not Yet Recruiting
Jinan Second People's Hospital Jinan Shandong Not Yet Recruiting
Qingdao Eye Hospital Of Shandong First Medical University Qingdao Shandong Not Yet Recruiting
Shanghai Tenth People's Hospital Shanghai Shanghai Municipality Not Yet Recruiting
TONG REN Hospital, Shanghai Jiao Tong University School Of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital Chengdu Sichuan Not Yet Recruiting
Tianjin Medical University Eye Hospital Tianjin Tianjin Municipality Not Yet Recruiting
Tianjin Medical University General Hospital Tianjin Tianjin Municipality Recruiting
Ningbo Eye Hospital Ningbo Zhejiang Not Yet Recruiting
The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Not Yet Recruiting

More Peking University People's Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07640997 on ClinicalTrials.gov ↗ ← All trials in China