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Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075188
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Salvatore Cillino, 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,

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Choroid Disease Drug: Aflibercept Injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 monthly
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : July 13, 2019

Resource links provided by the National Library of Medicine


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 Name: verteporfin for injection




Primary Outcome Measures :
  1. Corrected Distance Visual Acuity [ Time Frame: 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 [ Time Frame: twelve months ]
    measured as percentage of patients with subretinal or intraretinal fluid

  3. Retinal Thickness [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: twelve months ]
    Number of intravitreal injection administered in a year



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075188


Locations
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Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Investigators
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Principal Investigator: Salvatore Cillino, MD PhD AOUP Paolo Giaccone, Palermo
Publications:
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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: August 30, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salvatore Cillino, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo:
pachychoroid
polypoidal choroidal vasculopathy
Aflibercept
photodynamic therapy
Swept source OCT
Additional relevant MeSH terms:
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Choroidal Neovascularization
Choroid Diseases
Vascular Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Uveal Diseases
Eye Diseases
Cardiovascular Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents