Treatment of Polypoidal Choroidal Vasculopathy in Pachychoroid

Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Study ID
NCT04075188
Status
Completed

Conditions

  • Choroid Disease
  • Choroidal Neovascularization

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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,

Key Dates

Start date
Sep 18, 2017
Status verified
Aug 2019
Primary completion
Jun 1, 2018
Completion
Jul 13, 2019

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Corrected Distance Visual Acuity [ Time Frame: twelve months ]

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