Safety and Efficacy of Intravitreal Conbercept Injection After Vitrectomy for the Treatment of Early Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- best corrected visual acuity
研究概览
简要总结
To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR).
Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.
详细描述
The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not.
At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed.
The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications
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
- 28 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR.
- •Patients with non-clearing VH and fibrocellular proliferation without TRD who underwent PPV at Tianjin Medical University Eye Hospital were included in the study.
排除标准
- •A history of previous PPV;
- •Severe intraoperative complications
- •Postoperative silicone oil tamponade;
- •Menstruation;
- •Stroke, a thromboembolic event, or myocardial infarction in the previous
- •months contraindicating the withdrawal of anti-platelet and anti-coagulant medications.
研究组 & 干预措施
Conbercept
intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery
干预措施: Conbercept (Drug)
结局指标
主要结局
best corrected visual acuity
时间窗: baseline to 24 weeks post-surgery
BCVA using a Landolt C acuity chart method
次要结局
- postoperative complications(baseline to 24 weeks post-surgery)
- central retinal thickness(baseline to 24 weeks post-surgery)
研究者
Zhenchuan Zheng
Tianjin Medical University Eye Hospital
Tianjin Medical University Eye Hospital