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)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept Intravitreous Injection — DRUG
  Patients will be given IVT injection(s) of IMP using standard injection techniques.

Study Details

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.

Key Dates

Start date

Jan 1, 2026

Status verified

Jan 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

174 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Arm B
  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.
• Other: Arm A
  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.

Primary Outcome Measure

Best Corrected Visual Acuity (BCVA) change at Week 52 after baseline in different treatment regimens. [ Time Frame: up to 52 Weeks ]

Central Contacts

• Xiaodong Sun
  +86-13651765503
  [email protected]