NCT07389980

Prospective Trial of the Efficacy and Safety of a Personalized Regimen of High-dose Aflibercept 8mg on Treatment-naive Polypoidal Choroidal Vasculopathy: the PALLAS Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Yeungnam University College of Medicine · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polypoidal Choroidal Vasculopathy
• Polypoidal Choroidal Vasculopathy (PCV)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-12-24
• Primary completion: 2028-11-01
• Completion: 2028-12-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: South Korea