A Phase 3 interventional study of aflibercept 8 mg in Polypoidal Choroidal Vasculopathy and Polypoidal Choroidal Vasculopathy (PCV), sponsored by Yeungnam University College of Medicine. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Yeungnam University College of Medicine · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.
Exclusion Criteria:
The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively.
Drug: aflibercept 8 mg
The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively.
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96
Time frame: Week 96
Last injection interval at week 96
Time frame: Week 96
Best corrected visual acuity (BCVA) at weet 96
Measurement with the Early Treatment Diabetic Retinopathy Study (ETDRS) letters score
Time frame: Week 96
Central retinal thickness and choroidal thickness at week 96
Average retinal thickness at the central 1 mm diameter
Time frame: Week 96
umber of participants with treatment-related adverse events
Slit lamp examination and fundoscopy
Time frame: Week 96
Plan to share: Undecided
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Polypoidal Choroidal Vasculopathy→
Yeungnam University College of Medicine