Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07365371

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
Phase
Phase 4
Study type
Interventional
Enrollment
174 (estimated)
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGAflibercept Intravitreous InjectionPatients will be given IVT injection(s) of IMP using standard injection techniques.

Timeline

Start date
2026-01-01
Primary completion
2027-12-31
Completion
2027-12-31
First posted
2026-01-26
Last updated
2026-01-26

Locations

20 sites across 1 country: China

Source: ClinicalTrials.gov record NCT07365371. Inclusion in this directory is not an endorsement.