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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Patients will be given IVT injection(s) of IMP using standard injection techniques.
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
The Second People's Hospital Of Foshan
Foshan, Guangdong, China
The First Affiliated Hospital Of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital Of Wuhan University
Wuhan, Hubei, China
Jiangsu Province Hospital , The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Norman Bethune Hospital Of Jilin University
Jilin, Jilin, China
Xi' AN No.1 Hospital
Xi'an, Shaanxi, China
...and 10 more locations
Best Corrected Visual Acuity (BCVA) change at Week 52 after baseline in different treatment regimens.
BCVA (study eye and the fellow eye) examination
Time frame: up to 52 Weeks
Percentage of patients gaining >15, >10, or ≥5 letters in BCVA after baseline
BCVA (study eye and the fellow eye) examination
Time frame: up to 52 Weeks
Percentage of patients achieving complete polypoidal lesion regression at Weeks 52
SD-OCT Spectral Domain Optical Coherence Tomography, FA Fluorescein Angiography, ICGA Indocyanine Green Angiography, OCT-A Optical Coherence Tomography Angiography, FP Fundus Photography examinations
Time frame: up to 52 Weeks
Percentage of patients with no active polypoidal lesion at Week 52
SD-OCT Spectral Domain Optical Coherence Tomography, FA Fluorescein Angiography, ICGA Indocyanine Green Angiography, OCT-A Optical Coherence Tomography Angiography, FP Fundus Photography examinations
Time frame: up to 52 Weeks
Change from baseline in central subfield thickness (CST) at Week 12 and 52.
SD-OCT Spectral Domain Optical Coherence Tomography examination
Time frame: up to 12 and 52 Weeks
BCVA change from baseline at Week 12
BCVA (study eye and the fellow eye) examination
Time frame: up to 12 Weeks
Percentage of patients achieving Q8W, Q12W, and Q16W treatment intervals at Week 52 in Arm B.
Calculating the ratio
Time frame: up to 52 Weeks
Percentage of patients achieving Q20W of last assigned interval at Week 52 in Arm B.
Calculating the ratio
Time frame: up to 52 Weeks
Percentage of patients achieving ≥12-week, ≥16-week and ≥20-week treatment intervals after completing loading doses in Arm A.
Calculating the ratio
Time frame: up to 52 Weeks
Total number of intravitreal injections administered through Week 52 in both arms.
Counting
Time frame: up to 52 Weeks
Incidence and severity of ocular & non-ocular adverse events.
Recording of adverse events
Time frame: up to 52 Weeks
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