Efficacy and Safety of Intravitreal Aflibercept Injection for Subacute Central Serous Chorioretinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- Changes of central subfield thickness from baseline with time
研究概览
简要总结
Central serous chorioretinopathy (CSC) is a self-limiting disease that usually associated with good visual prognosis. In some cases, however, CSC may persist and result in permanent retinal or retinal pigment epithelium (RPE) damage. Therefore, if the disease is persistent beyond the acute phase, an active treatment should be considered to prevent an irreversible damage to retinal function.
The pathophysiology of CSC is associated with abnormal choroidal circulation. Indocyanine green angiography (ICGA) has revealed dilated and congested choroidal vessel and leakage into the extracellular space that appears as area of hyperfluorescence seen in middle and late phase in eyes with CSC.
A goal of treatment has been focused on reducing choroidal hyperpermeability. Currently, photodynamic therapy with verteporfin (PDT) and intravitreal anti-VEGF (vascular endothelial growth factor)antibody injection are being tried in order to treat chronic CSC. PDT reduces choroidal hyperpermeability by inducing hypoperfusion of the choriocapillaris in the short term and choroidal vascular remodeling over time. Intravitreal anti-VEGF injection for the treatment of CSC also effectively reduces choroidal hyperpermeability by blocking vascular leakage. Both methods have shown to be effective with good functional outcome for treating chronic CSC in many reports, but until now there is no established standard treatment protocol for chronic CSC.
Bevacizumab (Avastin) and ranibizumab (Lucentis) have been used widely as anti-VEGF therapeutic agent for the treatment of age related macular generation (AMD) and macular edema of various reasons. A newly developed anti-VEGF drug, aflibercept (Eylea○R), shows higher affinity to VEGF and has a longer duration of effect in the vitreous.FDA approved aflibercept to treat wet type AMD and macular edema due to central retinal vein occlusion.
Until now, no study has been reported on the efficacy and safety of aflibercept for treating CSC. The aim of this study is to evaluate the efficacy and safety of intravitreal aflibercept injection for the treatment of idiopathic CSC
详细描述
Single-center Double blind randomized Phase 2 interventional parallel study.
Group A : 2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2 month Group B : Sham injection at baseline, at 1 month, and at 2 month
At 3 month, 4 month, 5 month, and 6 month, PRN treatment of aflibercept injection or half-fluence photodynamic therapy may be done, if one of following conditions is fulfilled.
The PRN treatment method was decided by investigator's discretion.
Of patient who had persistent intra- or subretina fluid on SD-OCT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of idiopathic CSC.
- •18 to 60 years old, woman and man.
- •Subretinal fluid is found at OCT.
- •Symptom duration is from 6 weeks to 4 months.
- •Patient who agree to participate in the study.
排除标准
- •Patient who was treated previously for CSC
- •Patient who has choroidal neovascularization or other macular disease
- •Patient who has other ophthalmologic disease that may affect patient's vision.
- •History of any intraocular surgery, except cataract extraction prior to 3 months
- •Patient who has active intraocular inflammation or infection
- •Patient who has uncontrolled glaucoma IOP was more than 25 mmHg in spite of anti-glaucoma medication Visual field defect which affect best corrected visual acuity
- •Patient who has been used systemic or topical carbonic anhydrase inhibitor within 1 month
- •Cushing syndrome
- •History of intravitreal steroid injection to study eye
- •Patient who has been used or plan to use systemic drug which is toxic to crystalline lens, retina or optic nerve.
- •Patient who has a known allergy to fluorescein or ICG
- •Pregnant or breast-feeding woman
- •Patient 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
Sham injection
Sham injection at baseline, at 1 month, and at 2 month
干预措施: Sham injection (Drug)
Sham injection
Sham injection at baseline, at 1 month, and at 2 month
干预措施: Half-fluence photodynamic therapy (Procedure)
Intravitreal Aflibercept injection
2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2 month
干预措施: Intravitreal Aflibercept injection (Drug)
Intravitreal Aflibercept injection
2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2 month
干预措施: Half-fluence photodynamic therapy (Procedure)
结局指标
主要结局
Changes of central subfield thickness from baseline with time
时间窗: at 1,2,3,4,5,6 month
次要结局
- Percentage of eyes achieving complete resolution of subretinal fluid(at 6 month)
- Percentage of eyes achieving 20/20 vision(at 6 month)
- Number of aflibercept injection to achieve a complete resolution(at 6 month)
- Change in subfoveal choroidal thickness from baseline using EDI-OCT(at 1,2,3,4,5,6 month)
- Adverse effect of intravitreal aflibercept (Eylea) injection(upto 6 month)
研究者
Young Hee Yoon
Professor
Asan Medical Center