Panretinal Photocoagulation (PRP) vs PRP Combined With Intravitreous Conbercept (IVC) for Severe Nonproliferative Diabetic Retinopathy (nPDR): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in best-corrected visual acuity (BCVA)
研究概览
简要总结
The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.
详细描述
This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.
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 (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 II diabetic patients, 18 years and older, were included if the participants had:
- •severe non-PDR in either eyes with/without diabetic macular edema;
- •ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
- •no previous treatment (of any type) in either eye.
排除标准
- •history of prior laser treatment or vitrectomy in the study eye;
- •history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
- •major surgery within the prior 6 months or planned within the next 28 days;
- •history of glaucoma or ocular hypertension;
- •loss of vision as a result of other causes;
- •history of systemic corticosteroid therapy within the last 3 months;
- •severe systemic disease other than diabetes mellitus;
- •known coagulation abnormalities or current use of anticoagulative medication other than aspirin
- •any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).
研究组 & 干预措施
Intravitreal conbercept+Panretinal coagulation
干预措施: Conbercept (Drug)
Intravitreal conbercept+Panretinal coagulation
干预措施: Panretinal coagulation (Procedure)
Panretinal coagulation
干预措施: Panretinal coagulation (Procedure)
结局指标
主要结局
Change in best-corrected visual acuity (BCVA)
时间窗: from baseline to month 12
To assess the effects of two therapies on visual acuity
次要结局
- Foveal avascular zone(from baseline to month 12)
- Change in central subfield thickness(from baseline to month 12)
- Fundus fluorescein angiography(from baseline to month 12)
研究者
Xi Shen
Department director of Ophthamology
Ruijin Hospital