Short-term Efficacy of Intravitreal Afilibercept Depending on Subtypes of Polypoidal Choroidal Vasculopathy: Polypoidal Choroidal Neovascularization or Idiopathic Choroidal Vasculopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Regression Rate of Polyp on Indocyanine Green Angiography
研究概览
简要总结
To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy
详细描述
The subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. All received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic typical PCV accompanying branch vascular network involving subfoveal area
- •signed informed consent; and
- •over 6 months follow-up period after enrollment.
排除标准
- •retinal diseases other than PCV
- •extrafoveal PCV not involving subfoveal area
- •massive subretinal hemorrhage blocking polypoidal lesion on ICGA
- •severe media opacity such as senile cataract
- •previous history of intravitreal injection
- •previous intraocular surgery history except cataract surgery which was done more than 3 months.
研究组 & 干预措施
Type 1 polypoidal choroidal vasculopathy
Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
干预措施: Aflibercept (Drug)
Type 1 polypoidal choroidal vasculopathy
Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
干预措施: Indocyanine green angiography (intraveonus indocyanine green dye) (Drug)
Type 2 polypoidal choroidal vasculopathy
Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
干预措施: Aflibercept (Drug)
Type 2 polypoidal choroidal vasculopathy
Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.
干预措施: Indocyanine green angiography (intraveonus indocyanine green dye) (Drug)
结局指标
主要结局
Regression Rate of Polyp on Indocyanine Green Angiography
时间窗: 3 months
Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased \>30%.
次要结局
- Best Corrected Visual Acuity(baseline, 3 months, and 6 monthsc)
研究者
Min Sagong
Assistant Professor
Yeungnam University College of Medicine