This study will evaluate patients with diagnosis of polypoidal choroidal vasculopathy (PCV) in pachychoroid treated with combined therapy, consisting in photodynamic therapy (PDT) and 3 intravitreal therapy (IVT) of Aflibercept monthly. This is a single center, prospective case-series study. The investigators are going to evaluate Corrected Distance Visual Acuity (CDVA), disease activity, retinal and choroidal thicknesses and number of injection per year, during a twelve month follow up. The aim of this study is to verify if the combined therapy can act on the insult induced by the pachychoroid and on the neovascular lesion itself in this sub-population of patients with PCV in pachychoroid,
This study evaluates patients with diagnosis of polypoidal choroidal vasculopathy (PCV) in pachychoroid treated with combined therapy, consisting in photodynamic therapy (PDT) and 3 intravitreal therapy (IVT) of Aflibercept monthly. Inclusion criteria are the presence of haemorrhagic or exudative PCV diagnosed by Optical Coherence Tomography (OCT) and Indocyanine Green Angiography (ICGA) and the mean central choroidal thickness \> 250 µm. Exclusion criteria comprehend ocular comorbidity, previous cardiovascular events and different ocular surgical procedures form cataract surgery. Participants undergo a thorough ophthalmic assessment that included best corrected visual acuity (CDVA), slit lamp biomicroscopy and dilated funduscopic examination. OCT, OCT-Angiography (OCT-A), ICGA and Fluoresceine Angiography (FA) were performed for all patients. The 12-month follow-up foresee monthly revaluations of the above measurements, excluding FA, repeated only on clinical judgement. CDVA will be measured using LogMAR. Choroidal and retinal thicknesses will be automatically measured by digital software OCT- integrated (IMAGEnet). All patients will be treated with a loading dose of Aflibercept combined with PDT within the first 7 days of the first intravitreal therapy. The spot size is calculated by adding 1000 μm to the greater linear dimension of the lesion. No additional therapy will be performed during follow-up unless signs of reactivation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Patients will be treated with combined therapy to determine the synergy of this treatment, causing anti- Vascular Endothelial Growth Factor (anti-VEGF) to block neovascular exudation and photodynamic therapy to close aneurismal vessel and reduce choroidal vascular congestion.
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Corrected Distance Visual Acuity
measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display)
Time frame: twelve months
Disease Activity
measured as percentage of patients with subretinal or intraretinal fluid
Time frame: twelve months
Retinal Thickness
Central retinal thickness (1 mm central foveal thickness) and mean macular thickness (second and the third 6-mm grid including parafoveal and perifoveal macular area)
Time frame: twelve months
Choroidal thickness
Central choroidal thickness (1 mm central subfoveal thickness) and mean choroideal thickness (second and the third 6-mm grid including parafoveal and perifoveal choroidal area)
Time frame: twelve months
Number of injections per year
Number of intravitreal injection administered in a year
Time frame: twelve months
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