Personalized high‑dose (8 mg) aflibercept treatment for treatment‑naive polypoidal choroidal vasculopathy

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

This study will test whether a personalized high‑dose (8 mg) aflibercept schedule, using flexible loading and 8–24 week treatment intervals, helps people with newly diagnosed PCV in the macula.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Yeungnam University College of Medicine (Academic / other)
• Locations: 1 site (Daegu)
• Trial ID: NCT07389980 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial gives participants intravitreal aflibercept 8 mg in a personalized regimen with a flexible loading phase and treatment intervals ranging from 8 to 24 weeks. Eligible eyes have active macular polypoidal lesions confirmed by ICGA and central retinal fluid on SD‑OCT, and vision within the specified ETDRS range. Participants are followed with visual acuity testing and retinal imaging (OCT, FA, ICGA) to monitor anatomical response and fluid, while safety and adverse events are recorded. The protocol targets treatment‑naive PCV and adapts dosing intervals based on individual disease activity.

Who should consider this trial

Good fit: Adults aged 19 or older with newly diagnosed, treatment‑naive PCV involving the macula, active polypoidal lesions on ICGA, central intraretinal or subretinal fluid on OCT, and BCVA between 23 and 83 ETDRS letters are ideal candidates.

Not a fit: People with prior treatment for PCV, other ocular conditions that could affect response or require surgery within 12 months, or vision outside the trial's BCVA range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve or stabilize vision while allowing longer gaps between injections, lowering treatment burden for people with PCV.

How similar studies have performed: Standard‑dose aflibercept and other anti‑VEGF agents have shown benefit in PCV, but personalized regimens using high‑dose (8 mg) aflibercept are relatively novel and less well studied.

Eligibility criteria

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.

Where this trial is running

Daegu

• Yeungnam University Hospital — Daegu, South Korea (Recruiting)

Study contacts

• Study coordinator: Sohee Shin

Conditions Polypoidal Choroidal Vasculopathy; PCV; PALLAS; Aflibercept 8 mg