Personalized high‑dose (8 mg) aflibercept treatment for treatment‑naive polypoidal choroidal vasculopathy
Official title: 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
Run by Yeungnam University College of Medicine · NCT07389980 · Data updated 2026-11-12
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 |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Yeungnam University College of Medicine Academic / other |
| Locations | 1 site (Daegu) |
| Status | Recruiting |
| Started | December 24, 2026 |
| Main results expected | November 2028 |
| Study ends | December 2028 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07389980 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Yeungnam University Hospital
Daegu, South Korea Recruiting
Study contacts
- Study coordinator: Sohee Shin
- Email: ey005@ymc.yu.ac.kr
- Phone: 82-53-620-3440
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.