Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

Choroidal Neovascularization Clinical Trial

Official title:

Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075188
• Other study ID #: PDT Aflibercept
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: July 13, 2019

Study information

• Verified date: August 2019
• Source: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 13, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Choroid Disease
• Choroidal Neovascularization
• Neovascularization, Pathologic
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. — View Citation

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

Yuzawa M, Mori R, Kawamura A. The origins of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2005 May;89(5):602-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Disease Activity	measured as percentage of patients with subretinal or intraretinal fluid	twelve months
Primary	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
Primary	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	Number of injections per year	Number of intravitreal injection administered in a year	twelve months