Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

August 30, 2019 updated by: Salvatore Cillino, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy

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,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
twelve months
Disease Activity
Time Frame: twelve months
measured as percentage of patients with subretinal or intraretinal fluid
twelve months
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)
twelve months
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)
twelve months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

July 13, 2019

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDT Aflibercept

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Choroidal Neovascularization

Clinical Trials on Aflibercept Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe