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RecruitingNCT07389980PALLASUpdated Feb 5, 2026

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

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

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Polypoidal Choroidal Vasculopathy
  • Polypoidal Choroidal Vasculopathy (PCV)

Keywords

  • PCV
  • Polypoidal Choroidal Vasculopathy
  • PALLAS
  • Aflibercept 8 mg
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • Drugaflibercept 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.

05

What researchers measure

Primary outcomes

  1. The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96

    Time frame: Week 96

Secondary outcomes

  1. Last injection interval at week 96

    Time frame: Week 96

  2. Best corrected visual acuity (BCVA) at weet 96

    Measurement with the Early Treatment Diabetic Retinopathy Study (ETDRS) letters score

    Time frame: Week 96

  3. Central retinal thickness and choroidal thickness at week 96

    Average retinal thickness at the central 1 mm diameter

    Time frame: Week 96

  4. umber of participants with treatment-related adverse events

    Slit lamp examination and fundoscopy

    Time frame: Week 96

06

Study locations

1 of 1 sites recruiting
  • Yeungnam University Hospital
    Daegu, 42415, South Korea
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07389980
Lead sponsor
Yeungnam University College of Medicine
Collaborators
Bayer
Responsible party
Min Sagong (Professor, Yeungnam University College of Medicine) — Principal investigator
First posted
Feb 5, 2026
Start date
Dec 24, 2026 (estimated)
Primary completion
Nov 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Feb 5, 2026

Study contacts

Sohee Shin
Contact
ey005@ymc.yu.ac.kr
82-53-620-3440

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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