Not Yet RecruitingPhase 4

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)

China174 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who fully understand the content, process, and possible AE of the study and capable of giving written informed consent form. * Male or female, age ≥ 50 years, at the time of signing the informed consent form. * Women of childbearing potential (WOCBP) must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom) during the study and for 4 months after discontinuation of study treatment. Women are considered not of childbearing potential if they are surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or \> 1 year postmenopausal. WOCBP must have negative results of pregnancy test at screening and must not be pregnant, breast feeding, lactating, or planning to become pregnant, breast feed or donate ova during the study and for 4 months after discontinuation of study treatment. * All male participants with female partners of childbearing potential must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom), and must agree to abstain from sperm donation during and for 4 months after participation in the study. * Ocular Inclusion Criteria for Study Eye: Sufficiently clear ocular media and adequate pupillary dilata…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best Corrected Visual Acuity (BCVA) change at Week 52 after baseline in different treatment regimens.

Timeframe: up to 52 Weeks

Trial details

NCT IDNCT07365371

SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Xiaodong Sun

+86-13651765503 xdsun@sjtu.edu.cn

View on ClinicalTrials.gov More Polypoidal Choroidal Vasculopathy (PCV) trials