Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.
PCV is regarded as a subtype of age-related macular degeneration (ARMD), but has several different features such as polypoidal terminal of new vessels, and relative resistance to anti-VEGF treatment. Other cytokines then VEGF are thought to be associated with development and progression of the disease. The aim of the this study is to investigate intraocular cytokines related to recurrence of polypoidal choroidal vasculopathy. Aqueous humor will be sampled from the anterior chamber at baseline, after loading injections of ranibizumab and at recurrence. The concentration of various cytokines will be measured in the aqueous humor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Ranibizumab 0.5mg is injected into the vitreous cavity through the pars plana using 30 gauge (or narrower) needle-attached syringe.
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Pusan National University Hospital
Busan, South Korea
Changes of VEGF-A from 8 weeks to 20 weeks
Intraocular concentration of VEGF-A is measured using multiplex immunoassay.
Time frame: 8 weeks and 20 weeks
Changes of the other cytokines from 8 weeks to 20 weeks
Intraocular concentration of the other cytokines including angiopoietin-1, interleukin-10 (IL-10), platelet-derived growth factor (PDGF) and placental growth factor (PlGF) is measured using multiplex immunoassay.
Time frame: 8 weeks and 20 weeks
Changes of cytokines from baseline to 8 weeks
Intraocular concentration of cytokines including VEGF, angiopoietin-1, IL-10, PDGF and PlGF is measured using multiplex immunoassay.
Time frame: baseline and 8 weeks
Correlation between time to recurrence and cytokine concentration at baseline and 8 weeks.
Time to recurrence is defined as number of weeks from 8 to recurrence. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
Time frame: baseline and 8 weeks
Correlation between vision changes and cytokine concentration changes
Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher score represents better functioning. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
Time frame: baseline and 24 weeks.
Correlation between CSMT and cytokine concentration
CSMT is central 1mm thickness of the macula measured using spectral-domain optical coherence tomography (OCT). Normal thickness is around 250μm. Increased CSMT is regarded as increase of en exudative sign. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
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Time frame: baseline, 8 weeks and 20 weeks.
Correlation between choroidal thickness and cytokine concentration
Choroidal thickness is thickness of the choroid measured at the foveal center using spectral-domain OCT. Increased choroidal thickness was reported to be related to poor response to anti-VEGF treatment. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
Time frame: baseline, 8 weeks and 20 weeks.
Correlation between area of new vessels and cytokine concentration
Area of new vessels is measured in indocyanine green angiography (ICGA) obtained at baseline. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation.
Time frame: baseline
Correlation between polyp closure and cytokine concentration changes
Polyp closure is defined as disappearance of polypoidal terminal in new vessels assessed in ICGA at 8 weeks. The difference of cytokine concentration is assessed between the closed group and un-closed group using non-parametric analysis, or Mann-Whitney U test.
Time frame: baseline and 8 weeks