Actively Recruiting
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
Led by Yeungnam University College of Medicine · Updated on 2026-02-05
50
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
Y
Yeungnam University College of Medicine
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Male or female aged 19 years or older at screening
- Active polypoidal lesions in the macula confirmed by ICGA with serosanguinous maculopathy shown on fundus photography, FA, and SD-OCT
- Presence of intraretinal fluid or subretinal fluid affecting the central subfield by SD-OCT
- Best-corrected visual acuity (BCVA) between 23 and 83 letters on ETDRS charts at screening and baseline (study eye)
You will not qualify if you...
- Eye conditions that may prevent treatment response, affect vision, or require surgery during the first 12 months; structural damage, atrophy, or fibrosis at the fovea center (study eye)
- History of type 2 or 3 neovascularization, myopic choroidal neovascularization, or other eye disorders
- Large subretinal hemorrhage area (>9DA or ≥50% of lesion) or vitreous hemorrhage in study eye
- Active intraocular or periocular infection or inflammation at screening or baseline (study eye)
- Uncontrolled glaucoma with intraocular pressure over 25 mmHg on medication or as judged by investigator (study eye)
- Prior ocular treatments including anti-VEGF drugs, steroids, macular laser, photocoagulation, PDT, or eye surgery except cataract surgery (study eye)
- Stroke or myocardial infarction within 6 months prior to baseline
- Any systemic anti-VEGF therapy at any time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yeungnam University Hospital
Daegu, South Korea, 42415
Actively Recruiting
Research Team
S
Sohee Shin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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