Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

Not Applicable

Completed

• Conditions: Choroidal Neovascularization; Choroid Disease
• Interventions: Drug: Aflibercept Injection

• Registration Number: NCT04075188
• Lead Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Brief Summary

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

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 Timeline

• Study Start: 2017-09-18
• Primary Completion: 2018-06-01
• Study Completion: 2019-07-13
• Status Verified: 2019-08
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-29
• Study First Posted: 2019-08-30
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined therapy	Aflibercept Injection	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.

Primary Outcome Measures

Name	Time	Method
Choroidal thickness	twelve months	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)
Disease Activity	twelve months	measured as percentage of patients with subretinal or intraretinal fluid
Retinal Thickness	twelve months	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)
Corrected Distance Visual Acuity	twelve months	measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display)

Secondary Outcome Measures

Name	Time	Method
Number of injections per year	twelve months	Number of intravitreal injection administered in a year

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone; 🇮🇹 Palermo, Italy