Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- The primary outcome is mean visual acuity change(BCVA)
研究概览
简要总结
Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function. Intravitreal injection of vascular endothelial growth factor(VEGF) can induce short-term regression of retinal neovascularization(NV). The purpose is to assess and compare the efficacy and safety between intravitreal injection of conbercept and PRP.
详细描述
Proliferative diabetic retinopathy (PDR) is a leading cause of vision loss in patients with diabetes mellitus,which of the initial manifestation of PDR is retinal neovascularization at the disc or elsewhere.Panretinal photocoagulation (PRP) has been the standard treatment for PDR since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function including peripheral visual field defects, night vision loss, loss of contrast sensitivity.Recent evidences have indicated that anti-vascular endothelial growth factor(VEGF) treatment can reduce the severity and delay the progression of DR.However,the impact of this treatment on visual function and the effect of anti-VEGF agents on retinal neovascularization compared with PRP remain unclear. It is possible that a long-acting anti-VEGF agent such as conbercept. So we design the study with is a prospective randomized controlled trial about Intravitreal injection of conbercept versus PRP on PDR.Primary outcome is the change in BCVA from screening to 12 months in the study eye measured in the ETDRS letter score at 4 m
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
- •Participants of either sex aged 18 years or over.
- •Diagnosis of diabetes mellitus (type 1 or 2).
- •Best-corrected visual acuity (BCVA) in the study eye better than or equal to 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
- •PDR with no evidence of previous PRP.
- •Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.
排除标准
- •a glycated haemoglobin (HbA1c) level of more than 10%;
- •Blood pressure > 180/100 mmHg
- •Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months
- •dialysis or renal transplant
- •Systemic anti-VEGF or pro-VEGF treatment within 6 months prior to randomization
- •For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years
- •Traction retinal detachment involving the macula
- •Exam evidence of neovascularization of the angle
- •History of major ocular surgery or anticipated within the next 6 months following randomization
研究组 & 干预措施
IVC group
intravitreal injection of conbercept (IVC) group：all study eyes randomised to receive conbercept will receive an intravitreal injection of conbercept 2 mg/ 0.05 mL at baseline and at 1 and 2 moths. Further treatment since months 3 is determined by the degree of regression of neovascularization (NV) of disc and elsewhere on clinical examination
干预措施: intravitreal injection of conbercept (Drug)
PRP group
panretinal photocoagulation (PRP) group:all study eyes randomised to receive PRP will receive an fill-in PRP in 1-2 two weekly sessions as per routine clinical practice with emphasis on targeting retinal nonperfusion areas
干预措施: PRP (Device)
结局指标
主要结局
The primary outcome is mean visual acuity change(BCVA)
时间窗: 12 months
Primary outcome is the change in BCVA from screening to 12 moths in the study eye measured in the ETDRS letter score at 4 m
次要结局
- the regression patterns of new vessels(6 months and 12 months)
- Visual acuity outcomes in terms of visual gain or loss(6 months and 12 months)
- proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy(12 months)
- change of visual field(12 months)
- change of retinal function(12 months)
- change of macular capillary density(12 months)
- change of central retinal thickness(12 months)
研究者
Jin Chen-jin
Director of ophthalmology, Principal Investigator, Clinical Professor
Sun Yat-sen University