search
Back to results

Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

Primary Purpose

Choroidal Neovascularization, Choroid Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aflibercept Injection
Sponsored by
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring pachychoroid, polypoidal choroidal vasculopathy, Aflibercept, photodynamic therapy, Swept source OCT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Number of injections per year
Number of intravitreal injection administered in a year

Full Information

First Posted
August 29, 2019
Last Updated
August 30, 2019
Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
search

1. Study Identification

Unique Protocol Identification Number
NCT04075188
Brief Title
Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid
Official Title
Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
July 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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,
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Choroid Disease
Keywords
pachychoroid, polypoidal choroidal vasculopathy, Aflibercept, photodynamic therapy, Swept source OCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection
Other Intervention Name(s)
verteporfin for injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Corrected Distance Visual Acuity
Description
measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display)
Time Frame
twelve months
Title
Disease Activity
Description
measured as percentage of patients with subretinal or intraretinal fluid
Time Frame
twelve months
Title
Retinal Thickness
Description
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)
Time Frame
twelve months
Title
Choroidal thickness
Description
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)
Time Frame
twelve months
Secondary Outcome Measure Information:
Title
Number of injections per year
Description
Number of intravitreal injection administered in a year
Time Frame
twelve months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Cillino, MD PhD
Organizational Affiliation
AOUP Paolo Giaccone, Palermo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15834093
Citation
Yuzawa M, Mori R, Kawamura A. The origins of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2005 May;89(5):602-7. doi: 10.1136/bjo.2004.049296.
Results Reference
background
PubMed Identifier
28983556
Citation
Koh A, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Feller C, Margaron P, Lim TH, Lee WK; EVEREST II study group. Efficacy and Safety of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Nov 1;135(11):1206-1213. doi: 10.1001/jamaophthalmol.2017.4030.
Results Reference
background
PubMed Identifier
30849345
Citation
Wong TY, Ogura Y, Lee WK, Iida T, Chen SJ, Mitchell P, Gemmy Cheung CM, Zhang Z, Leal S, Ishibashi T; PLANET Investigators. Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy: Two-Year Results of the Aflibercept in Polypoidal Choroidal Vasculopathy Study. Am J Ophthalmol. 2019 Aug;204:80-89. doi: 10.1016/j.ajo.2019.02.027. Epub 2019 Mar 6.
Results Reference
background
PubMed Identifier
25158945
Citation
Pang CE, Freund KB. Pachychoroid neovasculopathy. Retina. 2015 Jan;35(1):1-9. doi: 10.1097/IAE.0000000000000331.
Results Reference
background
PubMed Identifier
26414957
Citation
Balaratnasingam C, Lee WK, Koizumi H, Dansingani K, Inoue M, Freund KB. Polypoidal Choroidal Vasculopathy: A Distinct Disease or Manifestation of Many? Retina. 2016 Jan;36(1):1-8. doi: 10.1097/IAE.0000000000000774. No abstract available.
Results Reference
background
PubMed Identifier
28704255
Citation
Yanagi Y, Ting DSW, Ng WY, Lee SY, Mathur R, Chan CM, Yeo I, Wong TY, Cheung GCM. CHOROIDAL VASCULAR HYPERPERMEABILITY AS A PREDICTOR OF TREATMENT RESPONSE FOR POLYPOIDAL CHOROIDAL VASCULOPATHY. Retina. 2018 Aug;38(8):1509-1517. doi: 10.1097/IAE.0000000000001758.
Results Reference
background

Learn more about this trial

Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

We'll reach out to this number within 24 hrs