Comparison of Intravitreal Injection of Ranibizumab Versus Sham Injection Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy: a Single-center, Prospective Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- perioperative hemorrhage of the surgical eye
研究概览
简要总结
Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detachment. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge related complications.
详细描述
Eyes responding to panretinal photocoagulation can remain stable for decades, but incomplete responses and relapses can occur in a certain percent of diabetic patients showing as proliferative diabetic retinopathy. At present vitrectomy is the main intervention for those eyes with vitreous hemorrhage, proliferative membrane, and tractional retinal detachment. And the surgical procedure might be complicated because of intraoperative bleeding. And post-operative complications might be also involved. Perioperative use of intraocular anti-VEGF might be associated with less hemorrhage related complications and better visula acuity. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection one week before surgery. The investigators tried to make sure whether pre-operative injection of ranibizuman can reduce reduce intra-operative bleeding, reduce the frequency of using endodiathermy, decrease surgical time, improve microcurculation of retina, and elevte best-corrected visual acuity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •type I or type II diabetes
- •there is clear indications for vitrectomy due to proliferative membrane in the vitreoretinal interface, mild hemorrhage, or tractional retinal detachment
- •retinal large vessels could be detected within one PD away from the edge of optic disc by OCT
- •microcurculation could be detected by FFA in at least one quadrant
- •the patient could tolerant FFA examination
排除标准
- •a history of vitrectomy or scleral bucke in the included eye
- •retinal laser photocoagulation treatment within 90 days in the included eye
- •anti-VEGF treatment with 90 days in either eye
- •there is cocurrent neovascular glaucoma in the included eye
- •any reason that might hinde the procedure of vitrectomy, FFA OCT or the observation of ocular fudus
- •a history of cere-brovascular accident or heart stroke
- •renal failure
- •could not attend follow up regularly
研究组 & 干预措施
ranibizumab
Intravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy.
干预措施: ranibizumab (Drug)
ranibizumab
Intravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy.
干预措施: pars plana vitrectomy (Procedure)
control
Sham intravitreal injection one week before vitrectomy.
干预措施: sham (Drug)
control
Sham intravitreal injection one week before vitrectomy.
干预措施: pars plana vitrectomy (Procedure)
结局指标
主要结局
perioperative hemorrhage of the surgical eye
时间窗: 3 month
次要结局
- size of retinal non-perfusion area assessed by fluorescene angiography(3 month)
- macular retinal thickness assessed with optical coherance tomography(3 month)
- retinal vessel oxygen saturation measured with a retinal oximeter(3 months)
- best-corrected visual acuity(3 months)
研究者
Lin Lu
Director of Fundus Disease Center
Sun Yat-sen University