Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

Study Overview
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Brief Summary
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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,

Detailed Description
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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.

Official Title
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Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy

Conditions
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Choroidal Neovascularization, Choroid Disease

Intervention / Treatment
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* Drug: Aflibercept Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of haemorrhagic or exudative PCV diagnosed by OCT and ICGA Mean central choroidal thickness > 250 µm Exclusion Criteria: ocular comorbidity previous cardiovascular events different ocular surgical procedures form cataract surgery
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Selected patients with both diagnosis of polypoidal choroidal vasculoparthy and pachychoroid will be treated with combined therapy consisting in photodynamic therapy and 3 intravitreal therapy of Aflibercept monthly
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined therapy<br>Treatment consisting in photodynamic therapy (Verteporfin, 6 mg/m2 × Body Surface Area (BSA) = Total Drug Dose; Total Drug Dose ÷ 2.0 mg/mL = Volume of Reconstituted Verteporfin; 30 mL - Volume of Reconstituted Verteporfin = Volume of 5% dextrose in water. Light dose is 50 J/cm2 administered at an intensity of 600 mW/cm2. This dose is administered over 83 seconds) and 3 intravitreal therapy of Aflibercept (2 mg/0,05 ml)monthly, the first of which performed within 7 days from photodynamic therapy. | Drug: Aflibercept Injection<br>* 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.<br>* Other names: verteporfin for injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected Distance Visual Acuity | measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display) | twelve months | 
| Disease Activity | measured as percentage of patients with subretinal or intraretinal fluid | 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) | 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) | twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of injections per year | Number of intravitreal injection administered in a year | twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pachychoroid, polypoidal choroidal vasculopathy, Aflibercept, photodynamic therapy, Swept source OCT