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.
Age related macular degeneration (AMD) is one of the leading causes of blindness worldwide. In its exudative or wet form, choroidal neovascularization (CNV) causes an exudative maculopathy resulting in sudden loss of vision with severe effects on patients' quality of life. Intravitreal injections of anti-vascular endothelial growth factor agents (anti-VEGF) have become the mainstay of treatment for AMD CNV and has been shown to have favorable outcomes in most AMD CNV subtypes. In the Asian population, however, a particular subtype called polypoidal choroidal vasculopathy (PCV), which affects about 50% of exudative maculopathy, has been shown to have less favorable response to anti-VEGF therapy. The best treatment option for PCV has remained unclear. Current best evidence is from 2 recent randomized controlled trials, the EVEREST II trial which compares the efficacy of ranibizumab with or without photodynamic therapy (PDT) for treatment of PCV and the PLANET trial which compares Aflibercept monotherapy against a rescue PDT when Aflibercept is deemed ineffective. Both trials have reported significant improvement in visual outcomes, however there remain significant unanswered questions and unmet needs regarding the use of Aflibercept and PDT as the best treatment for PCV. In this study, we aim to compare the efficacy of combination Aflibercept with RF-PDT (at baseline) and Aflibercept monotherapy. This particular strategy has not been studies before and represents the amalgamation of unanswered questions from the best evidence to date for the treatment of PCV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Aflibercept dosage of 2mg in 0.05ml along with intravenous infusion of Verteporfin (6mg/m2)followed by laser light at a dosage of 25Joule/cm2
Aflibercept dosage of 2mg in 0.05ml along with sham photodynamic therapy
Singapore National Eye Centre
Singapore, Singapore, Singapore
National University Hospital
Singapore, Singapore
Polyp Closure rate
polyp closure rate at week 12 between the 2 treatment groups.
Time frame: 12 weeks
Optical Coherence Tomography
For evidence of intraretinal or subretinal fluid, ill-defined hyper-reflective material and/or new hemorrhage
Time frame: 12 months
Optical Coherence Tomography-Angiograph
For evidence of intraretinal or subretinal fluid, ill-defined hyper-reflective material and/or new hemorrhage
Time frame: 12 months
Color Fundus photography
inspect anomalies associated to diseases that affect the eye, and to monitor their progression
Time frame: baseline, month 3, month12
Autofluorescence Photography
Retinal imaging
Time frame: baseline, month 3, month12
Fundus Fluorescein Angiography
Retinal circulation
Time frame: Baseline, month 3, month 12
Intra Ocular Pressure (IOP)
Fluid Pressure in eye
Time frame: Baseline, 12 months
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