Intraocular Cytokine Changes in Recurrence of Polypoidal Choroidal Vasculopathy
试验速览
- 阶段
- 4 期
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Changes of VEGF-A from 8 weeks to 20 weeks
研究概览
简要总结
Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Submacular PCV diagnosed based on branching neovascular networks having polypoidal dilatation in ICGA.
- •Presence of exudative changes involving the fovea in OCT
- •Decreased visual acuity to 20/320 - 20/40 to be primarily the results of PCV in the study eye.
- •Willing and able to comply with clinic visits and study-related procedures, and provide a signed informed consent form.
排除标准
- •Extramacular PCV.
- •Presence of pathologic changes blocking 50% or more area of the lesion in angiography.
- •Any anti-VEGF treatment in the study eye within 180 days of day
- •Previous photodynamic therapy in the study eye.
- •History of intraocular surgery except uncomplicated cataract surgery performed before 90 days or more from day
- •Presence of exudative ARMD requiring anti-VEGF treatment in the other eye.
- •Presence of other ocular disease that may compromise visual acuity in the study eye.
- •Uncontrolled systemic disease.
- •Active intraocular or periocular infection.
- •Active intraocular inflammation.
- •Hypersensitivity to ranibizumab or excipients.
研究组 & 干预措施
pro-re-nata
Ranibizumab 0.5mg is injected in to the vitreous cavity. An injection is given every 4 weeks three times, and then the patient will be followed up every 4 weeks. An addition injection is given as needed. Recurrence is defined as increase of exudative changes, or increase of 10% or more in central subfield macular thickness (CSMT) measured using optical coherence tomography. Aqueous humor is sampled from the anterior chamber before injection at baseline, 8 weeks and 20 weeks.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Changes of VEGF-A from 8 weeks to 20 weeks
时间窗: 8 weeks and 20 weeks
Intraocular concentration of VEGF-A is measured using multiplex immunoassay.
次要结局
- Changes of cytokines from baseline to 8 weeks(baseline and 8 weeks)
- Correlation between time to recurrence and cytokine concentration at baseline and 8 weeks.(baseline and 8 weeks)
- Correlation between CSMT and cytokine concentration(baseline, 8 weeks and 20 weeks.)
- Correlation between choroidal thickness and cytokine concentration(baseline, 8 weeks and 20 weeks.)
- Correlation between area of new vessels and cytokine concentration(baseline)
- Changes of the other cytokines from 8 weeks to 20 weeks(8 weeks and 20 weeks)
- Correlation between vision changes and cytokine concentration changes(baseline and 24 weeks.)
- Correlation between polyp closure and cytokine concentration changes(baseline and 8 weeks)