Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

NCT04075188 | Completed

• 1 other identifier: PDT Aflibercept
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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,

Conditions

Choroidal Neovascularization; Choroid Disease

Keywords

pachychoroid; polypoidal choroidal vasculopathy; Aflibercept; photodynamic therapy; Swept source OCT

Outcome Measures

Primary Outcomes (4)

• Corrected Distance Visual Acuity

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

  twelve months

• Disease Activity

  measured as percentage of patients with subretinal or intraretinal fluid

  twelve months

• 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)

  twelve months

• 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)

  twelve months

Secondary Outcomes (1)

• Number of injections per year

  twelve months

Study Arms (1)

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.

Drug: Aflibercept Injection

Interventions

Aflibercept Injection DRUG

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.

Also known as: verteporfin for injection

Combined therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Related Publications (6)

• 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.

  PMID: 15834093 BACKGROUND

• 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.

  PMID: 28983556 BACKGROUND

• 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.

  PMID: 30849345 BACKGROUND

• Pang CE, Freund KB. Pachychoroid neovasculopathy. Retina. 2015 Jan;35(1):1-9. doi: 10.1097/IAE.0000000000000331.

  PMID: 25158945 BACKGROUND

• 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.

  PMID: 26414957 BACKGROUND

• 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.

  PMID: 28704255 BACKGROUND

MeSH Terms

Conditions

Choroidal Neovascularization; Choroid Diseases; Polypoidal Choroidal Vasculopathy

Interventions

aflibercept; Verteporfin; Injections

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Salvatore Cillino, MD PhD

  AOUP Paolo Giaccone, Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Ophthalmology Section of the Department of Biomedicine, Neurosciences and Advanced Diagnostic

Model Details: 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

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: September 18, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 13, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)