Exudative Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy
Conditions
Brief summary
Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.
Detailed description
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.
Interventions
DRUGranibizumab
Ranibizumab 0.5mg is injected into the vitreous cavity through the pars plana using 30 gauge (or narrower) needle-attached syringe.
Sponsors
Novartis
Pusan National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Submacular PCV diagnosed based on branching neovascular networks having polypoidal dilatation in ICGA. 2. Presence of exudative changes involving the fovea in OCT 3. Decreased visual acuity to 20/320 - 20/40 to be primarily the results of PCV in the study eye. 4. Willing and able to comply with clinic visits and study-related procedures, and provide a signed informed consent form.
Exclusion criteria
1. Extramacular PCV. 2. Presence of pathologic changes blocking 50% or more area of the lesion in angiography. 3. Any anti-VEGF treatment in the study eye within 180 days of day 1. 4. Previous photodynamic therapy in the study eye. 5. History of intraocular surgery except uncomplicated cataract surgery performed before 90 days or more from day 1. 6. Presence of exudative ARMD requiring anti-VEGF treatment in the other eye. 7. Presence of other ocular disease that may compromise visual acuity in the study eye. 8. Uncontrolled systemic disease. 9. Active intraocular or periocular infection. 10. Active intraocular inflammation. 11. Hypersensitivity to ranibizumab or excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of VEGF-A from 8 weeks to 20 weeks | 8 weeks and 20 weeks | Intraocular concentration of VEGF-A is measured using multiplex immunoassay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of cytokines from baseline to 8 weeks | baseline and 8 weeks | Intraocular concentration of cytokines including VEGF, angiopoietin-1, IL-10, PDGF and PlGF is measured using multiplex immunoassay. |
| Correlation between time to recurrence and cytokine concentration at baseline and 8 weeks. | 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. |
| Correlation between vision changes and cytokine concentration changes | baseline and 24 weeks. | 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. |
| Changes of the other cytokines from 8 weeks to 20 weeks | 8 weeks and 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. |
| Correlation between choroidal thickness and cytokine concentration | baseline, 8 weeks and 20 weeks. | 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. |
| Correlation between area of new vessels and cytokine concentration | baseline | 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. |
| Correlation between polyp closure and cytokine concentration changes | baseline and 8 weeks | 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. |
| Correlation between CSMT and cytokine concentration | baseline, 8 weeks and 20 weeks. | 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. |
Countries
South Korea
Outcome results
None listed