An Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Injection of VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- Percentage of Patients Lose Visual Acuity Less Than 15 Letters
研究概览
简要总结
Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.
详细描述
Efficacy of VEGF Trap-Eye (aflibercept, Eylea) for exudative age-related macular degeneration (AMD) was demonstrated in the phase III VIEW study. Polypoidal choroidal vasculopathy (PCV) is considered as a subtype of exudative AMD, however it is reportedly different from choroidal new vessels based on the histologic studies. The aim of this study is to evaluate effects of VEGF Trap-Eye in treatment of PCV, which was diagnosed using indocyanine green (ICG) angiography. VEGF Trap-Eye will be injected intravitreally bimonthly after 3 monthly loading dose for 12 months in treatment-naive PCV patients. The efficacy will be evaluated on preserving visual acuity and improving angiographic features at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Submacular PCV diagnosed using ICG angiography with no previous treatment (branching vascular network with or without polypoidal dilation in ICG angiography)
- •Presence of signs of recent activity of PCV
- •Visual acuity between 20/40 and 20/320
- •Active leakage in fluorescein angiography
- •Presence of any fluid in OCT(optical coherence tomography)-intraretinal, subretinal, sub-retinal pigment epithelial
排除标准
- •Extramacular PCV
- •Subretinal hemorrhage or other retinal lesions blocking angiographic characteristics in more than 50% area of PCV lesion.
- •Previous treatment of intravitreal injections (anti-VEGF, steroid or other agents)
- •Previous treatment of photodynamic therapy
- •Previous ocular surgery except cataract surgery before 3 or more months
- •Presence of exudative AMD in the other eyes requiring anti-VEGF treatment (Intravitreal bevacizumab was reported to affect the other eye.)
- •Presence of other ocular diseases which may affect visual acuity (glaucoma, cataract with opacity involving visual axis, etc)
- •Presence of uncontrolled systemic disease (diabetes mellitus, hypertension, ischemic heart disease, cerebral infarction, etc)
- •Patients who cannot understand or conform to the study protocol.
- •Patients who refuse to agree to the informed consent.
- •Patients with contraindication to aflibercept
- •Ocular or periocular infection
- •Active severe intraocular inflammation
- •Known hypersensitivity to aflibercept or to any of the excipients
研究组 & 干预措施
aflibercept
Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
干预措施: aflibercept (Drug)
结局指标
主要结局
Percentage of Patients Lose Visual Acuity Less Than 15 Letters
时间窗: 12 months
Visual acuity was 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 scores represents better functioning.
次要结局
- Change in Visual Acuity From Baseline to 12 Months(Baseline and 12 months)
- Percentage of Patients With Visual Acuity >=20/200(12 months)
- Percentage of Patients With Visual Acuity >=20/40(12 months)
- VFQ (Visual Function Questionaire)-25 Score(12 months)
- Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography(12 months)
研究者
Ji Eun Lee
Associate professor
Pusan National University Hospital