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

Recruiting Phase 3 Interventional Study
Polypoidal Choroidal Vasculopathy Polypoidal Choroidal Vasculopathy (PCV)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Yeungnam University College of Medicine · Other
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About This Trial

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.

Trial Locations
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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 hemorrhagi…
Contacts

Sohee Shin

82-53-620-3440

ey005@ymc.yu.ac.kr

CONTACT