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Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo (Other)
Overall Status
Completed
CT.gov ID
NCT04075188
Collaborator
(none)
17
Enrollment
1
Location
1
Arm
21.8
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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,

Condition or Disease Intervention/Treatment Phase
  • Drug: Aflibercept Injection
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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 monthlySelected 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)
Primary Purpose:
Treatment
Official Title:
Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy
Actual Study Start Date :
Sep 18, 2017
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jul 13, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combined therapy

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
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.
Other Names:
  • verteporfin for injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. Disease Activity [twelve months]

      measured as percentage of patients with subretinal or intraretinal fluid

    3. 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)

    4. 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)

    Secondary Outcome Measures

    1. Number of injections per year [twelve months]

      Number of intravitreal injection administered in a year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy 90127

    Sponsors and Collaborators

    • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

    Investigators

    • Principal Investigator: Salvatore Cillino, MD PhD, AOUP Paolo Giaccone, Palermo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Salvatore Cillino, Head of the Ophthalmology Section of the Department of Biomedicine, Neurosciences and Advanced Diagnostic, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
    ClinicalTrials.gov Identifier:
    NCT04075188
    Other Study ID Numbers:
    • PDT Aflibercept
    First Posted:
    Aug 30, 2019
    Last Update Posted:
    Sep 3, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Salvatore Cillino, Head of the Ophthalmology Section of the Department of Biomedicine, Neurosciences and Advanced Diagnostic, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
    pachychoroid
    polypoidal choroidal vasculopathy
    Aflibercept
    photodynamic therapy
    Swept source OCT
    Additional relevant MeSH terms:
    Choroidal Neovascularization
    Choroid Diseases
    Vascular Diseases
    Neovascularization, Pathologic
    Aflibercept
    Verteporfin

    Study Results

    No Results Posted as of Sep 3, 2019