Prospective Trial of the Efficacy and Safety of a Personalized Regimen of High-dose Aflibe
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.
| Condition(s) | Polypoidal Choroidal Vasculopathy, Polypoidal Choroidal Vasculopathy (PCV) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female patients ≥ 19 years of age at screening 3. Presence of active polypoidal lesions in the macular as shown by ICGA and presence of serosanguinous maculopathy (exudative or hemorrhagic features involving the macula on floor fundus photography, FA and SD-OCT AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT 4. Best-corrected visual acuity (BCVA) score between 83 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye) Exclusion Criteria: 1. Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prev |
| Ages | 19 Years |
| Sex | All |
| Lead sponsor | Yeungnam University College of Medicine |
| Locations | Daegu, South Korea |
| Start date | 2026-12-24 |
| NCT ID | NCT07389980 |
| Official listing | https://clinicaltrials.gov/study/NCT07389980 |