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A Prospective, Multicenter, Open-label, Randomized Clinical Trial to Evaluate the Efficacy, Durability, and Safety of Aflibercept 8mg in Different Treatment Regimens in Chinese Patients With Polypoidal Choroidal Vasculopathy (PCV)
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Summary
The goal of this clinical trial is to investigate the efficacy, durability, and safety of aflibercept 8 mg in treating Polypoidal Choroidal Vasculopathy (PCV) in Chinese naive patients. The main questions it aims to answer are: 1. What is the change in Best Corrected Visual Acuity (BCVA) at Week 52 from baseline in different treatment regimens? 2. What proportion of patients achieve sustained disease control after receiving the loading dose? Participants will: * Receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). * In Arm A: * Undergo reinjections based on disease activity, with follow-up examinations every 4 weeks until week 48. * Return for an end-of-study visit at week 52. * In Arm B: * Undergo an examination at week 12 and subsequent treatments based on disease activity, with a maximum interval of 20 weeks and a minimum interval of 8 weeks between doses if the disease remains inactive. * Return for an end-of-study visit at week 52. This study will assess the efficacy, safety and durability of aflibercept 8mg in these 2 regimens.
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2026-01-01
Completion Date
2027-12-31
Last Updated
2026-01-26
Healthy Volunteers
No
Interventions
Aflibercept Intravitreous Injection
Patients will be given IVT injection(s) of IMP using standard injection techniques.
Locations (20)
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
The Second People's Hospital Of Foshan
Foshan, Guangdong, China
The First Affiliated Hospital Of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital Of Wuhan University
Wuhan, Hubei, China
Jiangsu Province Hospital , The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Norman Bethune Hospital Of Jilin University
Jilin, Jilin, China
Xi' AN No.1 Hospital
Xi'an, Shaanxi, China
The First People's Hospital Of Xianyang
Xianyang, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Affiliated Hospital Of Shandong Second Medical University
Weifang, Shandong, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jiaxing Hospital of T.C.M
Jiaxing, Zhejiang, China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China