Prospective, Single-blind, Randomised, Controlled, Multi-centre Study to Evaluate the Benefit of Ranibizumab as an Adjunctive Therapy to Vitrectomy for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Oedema
试验速览
- 阶段
- 4 期
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- Early postoperative vitreous haemorrhage
研究概览
简要总结
To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
详细描述
Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.
Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.
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
- Single (Participant)
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
- •Age≥18 years old;
- •Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema
- •Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of PPV at the investigator's discretion
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
排除标准
- •Pregnancy or lactation;
- •History of stroke, peripheral vascular disease, angina or myocardial infarction within six months
- •Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline;
- •Clinically confirmed intraocular pressure (IOP) >=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye
研究组 & 干预措施
Ranibizumab
Single intravitreal injection of ranibizumab (0.5 mg) 3~7 days before vitrectomy
干预措施: Ranibizumab (Drug)
Ranibizumab
Single intravitreal injection of ranibizumab (0.5 mg) 3~7 days before vitrectomy
干预措施: Pars plana vitrectomy (Procedure)
Sham injection
Sham injection 3~7 days before vitrectomy
干预措施: Sham injection (Other)
Sham injection
Sham injection 3~7 days before vitrectomy
干预措施: Pars plana vitrectomy (Procedure)
结局指标
主要结局
Early postoperative vitreous haemorrhage
时间窗: From day 1 to week 4 after the vitrectomy
To compare the incidence of the early postoperative vitreous haemorrhage between two arms
次要结局
- Mean Best-corrected visual acuity (BCVA) at Month 6(Month 6 after vitrectomy)
- Mean Best-corrected visual acuity (BCVA) at Month 3(Month 3 after vitrectomy)