The Randomized Double-blind Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for Macular Edema Secondary to Branch Retinal Vein Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- visual acuity changes
研究概览
简要总结
To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term.
详细描述
To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in Chinese patients with visual impairment in ME due to BRVO.
The result of the trial will be used to support new therapy in the BRVO in China.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male or female Chinese patients ≥ 18 years of age with BRVO
- •Visual impairment due to ME secondary to BRVO in at least one eye with BCVA score between 73 and 24 and at least 24 letters in the other eye
排除标准
- •Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception
- •Stroke or myocardial infarction less than 3 months prior to screening visit
- •Renal failure or creatinine levels > 2.0 mg/dl
- •Uncontrolled hypertension
- •Active ocular infection or intraocular inflammation in any eye
- •Neovascularization of the iris or neovascular glaucoma in any eye
- •History of uveitis or vitreomacular traction in any eye
- •Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
- •Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye
- •Active proliferative diabetic retinopathy in study eye
- •Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit
- •Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
- •History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
- •History of vitrectomy in study eye
- •Other protocol defined inclusion /exclusion criteria may apply
研究组 & 干预措施
Ranibizumab only
Sham macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization
Interventions :Ranibizumab injection Interventions :Sham macular laser
干预措施: Ranibizumab (Drug)
Ranibizumab combined macular laser
Macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization
Interventions :Ranibizumab injection Interventions :Macular laser photocoagulation
干预措施: Ranibizumab combined macular laser (Procedure)
Ranibizumab combined macular laser
Macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization
Interventions :Ranibizumab injection Interventions :Macular laser photocoagulation
干预措施: Ranibizumab (Drug)
结局指标
主要结局
visual acuity changes
时间窗: one year
comparing the changes of visual acuity between the two groups
次要结局
未报告次要终点
研究者
Yu Xiaobing
M.D
Beijing Hospital