Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in subretinal fluid (microns)
研究概览
简要总结
Examine the efficacy of brinzolamide for the treatment of central serous chorioretinopathy
详细描述
Brinzolamide is a carbonic anhydrase inhibitor. Previously, carbonic anhydrase inhibitors have been shown to be effective for the treatment of macular edema when administered orally, also for central serous chorioretinopathy. However, this treatment carries the risk of severe side effects.
The goal of this study is to examine the efficacy of the topical form of treatment of carbonic anhydrase inhibitors in patients with chronic, non-resolving, central serous chorioretinopathy.
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
- 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
- •Central serous chorioretinopathy (CSC) affecting the fovea, non-resolving after 4 months of follow-up
- •Optical coherence tomography (OCT) shows foveal subretinal fluid
- •Fluorescein angiography and indocyanine green confirm the diagnosis
排除标准
- •Any other ophthalmic condition that may lead to subretinal fluid
- •Choroidal neovascularization
- •Myopia > -6D
- •Previous treatment for CSC in the past 6 months
- •Known allergy to fluorescein or indocyanin green
- •Known allergy for brinzolamide
- •Pregnancy, breast feeding
研究组 & 干预措施
Topical brinzolamide
Brinzolamide ophthalmic, given bd for 3 months
干预措施: Brinzolamide Ophthalmic (Drug)
结局指标
主要结局
Change in subretinal fluid (microns)
时间窗: 6 months
Change in subretinal fluid as measured by optical coherence tomography
次要结局
- Change in central macular thickness (microns)(6 months)
- Time for fluid resolution (days)(6 months)
- Percentage of patients with fluid resolution(6 months)
- Change in choroidal thickness (microns)(6 months)
- Quality of life assessment (using NEI-VFQ-25 questionnaires)(6 months)
- Change in ETDRS visual acuity (number of letters)(6 months)
研究者
Michaella Goldstein
Study Chair
Tel-Aviv Sourasky Medical Center