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
| NCT ID | NCT07389980 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Yeungnam University College of Medicine |
| Condition | Polypoidal Choroidal Vasculopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-12-24 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2026-12-24 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07389980 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Polypoidal Choroidal Vasculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07389980 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT07389980 currently recruiting?
Yes, NCT07389980 is actively recruiting participants. Contact the research team at ey005@ymc.yu.ac.kr for enrollment information.
Where is the NCT07389980 trial being conducted?
This trial is being conducted at Daegu, South Korea.
Who is sponsoring the NCT07389980 clinical trial?
NCT07389980 is sponsored by Yeungnam University College of Medicine. The trial plans to enroll 50 participants.