Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT i… (NCT03941587) | Clinical Trial Compass
CompletedNot Applicable
Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT in PCV Treatment
Singapore60 participantsStarted 2021-02-01
Plain-language summary
In this study, we aim to evaluate the efficacy and safety of an individualized dosing schedule comprising Aflibercept and RF-PDT in patients with polypoidal choroidal vasculopathy (PCV). The primary objective is to compare the polyp closure rate at week 12 between the 2 treatment groups. The secondary aims include comparing visual, anatomical, treatment burden and clinical biomarkers between each treatment group.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Patients aged over 50 years old at the time of informed consent.
* Provide written informed consent.
* Willingness and ability to comply with all scheduled visits and study procedures.
* Confirmed diagnosis of symptomatic macular PCV based ICGA.
* Activity of PCV confirmed by exudative activity involving the macula on OCT or Fluorescein Angiography (FA) or both.
* Presence of intra retinal or subretinal fluid/blood as seen on OCT
* Treatment naïve
* NO previous treatment with intravitreal anti-VEGF agents, regardless of the indication
* NO previous thermal laser in the macular region, or verteporfin photodynamic therapy (vPDT), regardless of indication
* NO other previous treatment for neovascular AMD (nAMD), except oral supplements and traditional Chinese medicine
* An ETDRS BCVA of at least 4 letters (Snellen equivalent approximately 20/800 or better) in the study eye.
* Greatest Linear Dimension (GLD) of the total lesion area (BVN + polyps) \<5400µm (\~9 mucopolysaccharidoses (MPS) Disc Areas) as delineated by ICGA.
Exclusion Criteria: - Participant
* Medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
* Participation in an investigational trial within 30 days of enrollment which involves treatment with unapproved investigational drug.
* Known allergy to any component of the study…