Prospective Study on the Efficacy and Safety of Intravitreal Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.
详细描述
Central serous chorioretinopathy (CSC) is characterized by serous detachment of the neurosensory retina. The pathophysiology of CSC is not certain and various theories are proposed including impaired function of retinal pigment epithelium (RPE), choroidal ischemia and choroidal hyperpermeability leading to RPE damage. Acute CSC with monofocal or paucifocal changes of RPE usually shows spontaneous resolution and has a favorable visual outcome. Chronic CSC is characterized by multifocal or diffuse decompensation of RPE associated with persistent detachment of neurosensory retina. This might lead to cystoid macular degeneration, foveal atrophy and damage to the foveal photoreceptor layer, consequently resulting in irreversible significant visual loss. Photodynamic therapy (PDT) was proposed for the treatment of chronic CSC. Modified parameters of PDT such as shortening of the time of laser emission and reduction of a total light energy have been suggested to reduce the irreversible damages induced by conventional PDT. Recently, intravitreal injection of antibody to vascular endothelial growth factor(VEGF) was proposed as a new treatment option based on the effect of anti-permeability. Several reports demonstrated acceptable outcomes after intravitreal bevacizumab injection, one of anti-VEGF agent. But the clinical results with ranibizumab are not reported yet. The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of chronic CSC.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •best-corrected visual acuity (BCVA) between 0.0 and 1.0 logarithm of the minimal angle of resolution (logMAR)
- •presence of subfoveal fluid persisting for 3 months or more on optical coherence tomography (OCT)
- •presence of leakage and multifocal/diffuse RPE decompensation on fluorescein angiography (FA)
- •choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on indocyanine angiography (ICGA)
排除标准
- •previous treatment, such as laser photocoagulation, PDT, intravitreal injection of steroid or anti-VEGF agent
- •evidence of choroidal neovascularization
- •any other ocular diseases that could affect visual acuity
- •systemic steroid treatment in the previous 12 months
- •media opacity such as cataract that could interfere with adequate acquisition of OCT, FA and ICGA images
研究组 & 干预措施
Low-fluence PDT with Verteporfin
Half the regular laser fluence PDT(Visudyne®; Novartis); a total light energy of 25J/cm2, a light dose rate of 300mW/cm2. If subretinal fluid was sustained after primary treatment, rescue treatment(ranibizumab injection) was considered
干预措施: Verteporfin (Drug)
Ranibizumab
Consecutive Intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months. If subretinal fluid was sustained after primary treatment, rescue treatment(low-fluence photodynamic therapy) was considered
干预措施: ranibizumab (Drug)
结局指标
主要结局
Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment
时间窗: 12 months
number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study
次要结局
- Number of Participants With Leakage on Fluorescein Angiography(12 months)
- Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography(12 months)
- Number of Participants Who Underwent Rescue Treatment(12 months)
- Number of Participants With Adverse Event(12 months)
- Change From Baseline in logMAR BCVA(12 months)
- Change From Baseline in Central Foveal Thickness on OCT(12 months)
研究者
Jang Won Heo
Associate professor
Seoul National University Hospital