NCT03633266Unknown不适用
Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 主要终点
- Mean change from baseline in best-corrected visual acuity (BCVA)
研究概览
简要总结
To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old;
- •type 1 or type 2 diabetes.
- •proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
- •The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus
排除标准
- •Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
- •Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
- •anterior chamber neovascularization or neovascular glaucoma;
- •other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
- •received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.
结局指标
主要结局
Mean change from baseline in best-corrected visual acuity (BCVA)
时间窗: 3 years
Assessed using the ETDRS protocol
次要结局
- chang from baseline in sructure of retina(3 years)
- Mean change from baseline in visual field(3 years)
- chang from baseline in retinal neovascularization(3 years)
研究者
Xiangtian Zhou
professor
Wenzhou Medical University
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