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)

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-12-31

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.

• Phase: PHASE4

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborator: Bayer