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 (PALLAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Polypoidal Choroidal Vasculopathy; Polypoidal Choroidal Vasculopathy (PCV)
• Intervention / Treatment: Drug: aflibercept 8 mg

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sohee Shin; Phone Number: 82-53-620-3440; Email: ey005@ymc.yu.ac.kr

Study Locations

• South Korea
  • Daegu, South Korea, 42415
    • Recruiting
    • Yeungnam University Hospital
    • Contact: Sohee Shin; Phone Number: 82-53-620-3440; Email: ey005@ymc.yu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
2. A history of any evidence of type 2 or type 3 neovascularization, myopic choroidal neovascularization, or other ocular disorders
3. Total area of subretinal hemorrhage larger than 9DA or comprising ≥ 50% of the lesion area or presence of vitreous hemorrhage in study eye
4. Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
5. Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye)
6. Ocular treatments: any anti-VEGF drugs, intraocular or periocular steroids, macular laser photocoagulation or PDT, previous ocular surgery except cataract surgery (study eye)
7. Stroke or myocardial infarction during the 6-month period prior to baseline
8. Systemic anti-VEGF therapy at any time.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96	Week 96

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Last injection interval at week 96		Week 96
Best corrected visual acuity (BCVA) at weet 96	Measurement with the Early Treatment Diabetic Retinopathy Study (ETDRS) letters score	Week 96
Central retinal thickness and choroidal thickness at week 96	Average retinal thickness at the central 1 mm diameter	Week 96
umber of participants with treatment-related adverse events	Slit lamp examination and fundoscopy	Week 96

Collaborators and Investigators

• Sponsor: Yeungnam University College of Medicine
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Estimated): December 24, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Polypoidal Choroidal Vasculopathy; PCV; Aflibercept 8 mg; PALLAS
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic; Pathological Conditions, Signs and Symptoms; Polypoidal Choroidal Vasculopathy; aflibercept
• Other Study ID Numbers: 2025-10-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No