Randomized, Double Blinded, Controlled, Two-center Study Assessing the Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
试验速览
- 阶段
- 2 期
- 发起方
- Attila Vajas
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Efficacy of preoperative intravitreal ranibizumab
研究概览
简要总结
This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.
详细描述
This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.
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 (Participant, Investigator)
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
- •male or female 18 or older who have signed an informed consent
- •Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
- •study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
- •study eye vision decrease must be resulted from severe PDR
排除标准
- •Active ocular inflammation or infection
- •History of uveitis
- •Uncontrolled glaucoma
- •High myopia
- •Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
- •Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye
- •History of vitrectomy within 60 days preceding Day 1 in the study eye
- •History of intraocular surgery within 30 days preceding Day 1 in the study eye
- •Untreated diabetes mellitus
- •Severe hypertension (systolic pressure higher than 160mmHg)
- •Current use of systemic medications known to be toxic to the retina
- •History of thromboembolic events (incl MI and stroke) within 5 years
- •Major surgery within previous 3 months or planned within the next 28 days
- •Known coagulation abnormalities or current use of anticoagulative medications other than aspirins
- •Known hypersensitivity to ranibizumab or any component of it
- •Women of childbearing potential unless 2 methods of birth control applied
- •Pregnant or lactating women
研究组 & 干预措施
vitrectomy with ranibizumab
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
干预措施: ranibizumab and vitrectomy (Drug)
vitrectomy without ranibizumab
Patients receiving sham treatment before vitrectomy as a comparator arm
干预措施: vitrectomy without preoperative ranibizumab (Procedure)
结局指标
主要结局
Efficacy of preoperative intravitreal ranibizumab
时间窗: OP day
Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
次要结局
- Change in BCVA.(6 months)
- Effect in anatomical changes.(3 ±1 days after injection)
- Retinal circulation integrity.(Month 1, 3, 6.)
- Safety.(Over 6 months.)