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)

NCT07365371 | Not Yet Recruiting Phase 4

• 1 other identifier: 23106
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 20

Brief 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:

• 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.

Conditions

Polypoidal Choroidal Vasculopathy (PCV); Neovascular Age Related Macular Degeneration (AMD)

Keywords

Polypoidal Choroidal Vasculopathy (PCV); Neovascular age related macular degeneration (AMD); Aflibercept 8mg

Outcome Measures

Primary Outcomes (1)

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

  BCVA (study eye and the fellow eye) examination

  up to 52 Weeks

Secondary Outcomes (10)

• Percentage of patients gaining >15, >10, or ≥5 letters in BCVA after baseline

  up to 52 Weeks

• Percentage of patients achieving complete polypoidal lesion regression at Weeks 52

  up to 52 Weeks

• Percentage of patients with no active polypoidal lesion at Week 52

  up to 52 Weeks

• Change from baseline in central subfield thickness (CST) at Week 12 and 52.

  up to 12 and 52 Weeks

• BCVA change from baseline at Week 12

  up to 12 Weeks

Study Arms (2)

Arm A

OTHER

All enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). Subsequent reinjections will be given according to the changes in patients' disease activity. If no retreatment criteria are met, no additional injections will be given, and patients will undergo follow-up examinations (including ETDRS visual acuity, findus photography, OCT-A and SD-OCT) every 4 weeks until week 48. Patients will return to the Clinical Research Unit (CRU) for an end-of-study (EOS) visit at week 52.

Drug: Aflibercept Intravitreous Injection

Arm B

OTHER

All enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). All patients in this group will undergo an examination at week 12, including ETDRS visual acuity, fundus photography, OCT-A and SD-OCT. Subsequent treatment regime will depend on disease activity. If disease is considered inactive, the next dose will occur at week 16 (8 week interval from last dose at week 8) and subsequent dose and visit will be extended by 4 weeks up to a maximum interval of 20 weeks and minimum interval of 8 weeks between treatments if disease remains quiescent. If signs of activity are noted at any visit point, visit interval will be reduced by 4 weeks. The last dose will be administered no later than week 48. Patients will return to the CRU for an EOS visit at week 52.

Drug: Aflibercept Intravitreous Injection

Interventions

Aflibercept Intravitreous Injection DRUG

Patients will be given IVT injection(s) of IMP using standard injection techniques.

Arm A; Arm B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Treatment with investigational therapy (anti-VEGF, corticosteroid, laser photocoagulation, panretinal or macular, and PDT) or approved medications for PCV treatment prior to initiation of study treatment on study Day 1.
• Allergy or hypersensitivity to any of the compounds/excipients in the study interventions formulations.
• Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg). Participants may be treated with up to 3 agents known to have anti-hypertensive effects for arterial hypertension to achieve adequate blood pressure control. This limit applies to drugs that could be used to treat hypertension even if their primary indication in the participant was not for blood pressure control. Any recent changes in medications known to affect blood pressure need to be stable for 12 weeks prior to screening.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the participant at high risk for treatment complications.
• Any other conditions that the Investigator considers may affect the patients' informed consent or adherence to the study protocol, completion of the test according to the study procedure, or the patients' participation in the test may affect the test results or their own safety.
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Bayer: collaborator

Study Sites (20)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Location

The Second People's Hospital Of Foshan

Foshan, Guangdong, China

Location

The First Affiliated Hospital Of Harbin Medical University

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Renmin Hospital Of Wuhan University

Wuhan, Hubei, China

Location

Jiangsu Province Hospital , The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location

Affiliated Eye Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The Second Norman Bethune Hospital Of Jilin University

Jilin, Jilin, China

Location

Xi' AN No.1 Hospital

Xi'an, Shaanxi, China

Location

The First People's Hospital Of Xianyang

Xianyang, Shaanxi, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Affiliated Hospital Of Shandong Second Medical University

Weifang, Shandong, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanxi Eye Hospital

Taiyuan, Shanxi, China

Location

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunan, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Jiaxing Hospital of T.C.M

Jiaxing, Zhejiang, China

Location

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaodong Sun

CONTACT

+86-13651765503; xdsun@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Shanghai General Hospital

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 26, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)