Different Conbercept Injection Methods in Treatment of Severe Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Best-corrected Visual Acuity
研究概览
简要总结
To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.
详细描述
To assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in pars plana vitrectomy (PPV) with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods. These patients were randomly assigned to three groups: Group 1 received an IVC injection 3 to 5 days before surgery; Group 2 received an IVC injection at the end of surgery; and Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. Follow-up examinations were performed for at least six months after surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either sex aged ≥ 18 years.
- •Diagnosis of diabetes mellitus (type 1 or type 2);
- •Active proliferative diabetic retinopathy was clinically evident;
- •Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage with significant fibrous proliferation, tractional retinal detachment in the posterior pole or complicated retinal detachment, which can be detected by B-scan ultrasonography.
- •Ability to give informed consent.
排除标准
- •Coexistent ocular disease that may interfere with visual outcome;
- •Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF) pharmacotherapy in either eye;
- •A macula-involving retinal detachment for >6 months in the study eye;
- •Iris or angle neovascularization and neovascular glaucoma;
- •known allergy to any components of conbercept formulation
- •severe external ocular infection;
- •pregnancy or current oral contraceptive intake;
- •usage of anticoagulant or antiplatelet therapy;
- •preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c) >11.0%];
- •uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases;
- •<6 months of follow-up post initial surgery.
研究组 & 干预措施
IVC Preoperative group
Conbercept injection before vitrectomy
干预措施: Conbercept (Drug)
IVC Postoperative group
Conbercept injection at the end of vitrectomy
干预措施: Conbercept (Drug)
IVC Pre- and Post-operative group
First conbercept injection before vitrectomy and second at the end of operation.
干预措施: Conbercept (Drug)
结局指标
主要结局
Best-corrected Visual Acuity
时间窗: 6 months
Duration of Surgery
时间窗: during the operation time
To evaluate the influence of these three methods to the final duration of surgery. We carefully estimated the time of the vitrectomy from insertion to extraction of the 23-gauge three-port trocars.
Intraoperative Bleeding
时间窗: Time between the insertion and extraction of three 23-gauge vitrectomy ports
The grading criteria for intraoperative bleeding: Grade 1, spontaneous cessation of minor bleeding or bleeding that stopped by transient elevation of perfusion pressure; Grade 2, moderate bleeding requiring endodiathermy or broad blood clots formed far away from the bleeding site; Grade 3, thick blood clots exceeding half of the posterior pole or affecting the operation field.
次要结局
- Number of Participants With Neovascular Glaucoma (NVG)(follow up period, up to an average of 6 months after the operation)
- Recurrent Retinal Detachment(follow up period, up to an average of 6 months after the operation)
- Reabsorption Time of Blood(follow up period, up to an average of 6 months after the operation)
- Need for Reoperation(follow up period, up to an average of 6 months after the operation)
- Postoperative Preretinal Blood(postoperatively, up to 1 week)
- Frequency of Intraoperative Electrocoagulation(during the operation time)
- Recurrent Vitreous Hemorrhage(follow up period, up to an average of 6 months after the operation)