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临床试验/NCT04075188
NCT04075188已完成不适用

Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年9月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Choroidal thickness

研究概览

简要总结

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,

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • presence of haemorrhagic or exudative PCV diagnosed by OCT and ICGA
  • Mean central choroidal thickness > 250 µm

排除标准

  • ocular comorbidity
  • previous cardiovascular events
  • different ocular surgical procedures form cataract surgery

研究组 & 干预措施

Combined therapy

Experimental

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.

干预措施: Aflibercept Injection (Drug)

结局指标

主要结局

Choroidal thickness

时间窗: 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

时间窗: twelve months

measured as percentage of patients with subretinal or intraretinal fluid

Corrected Distance Visual Acuity

时间窗: twelve months

measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display)

Retinal Thickness

时间窗: 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)

次要结局

  • Number of injections per year(twelve months)

研究者

发起方
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Salvatore Cillino

Head of the Ophthalmology Section of the Department of Biomedicine, Neurosciences and Advanced Diagnostic

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

研究点 (1)

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