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NOT YET RECRUITING
NCT07365371
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

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