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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)

NCT07365371 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Aflibercept Intravitreous Injection

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07365371 on ClinicalTrials.gov