Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 248
- 试验地点
- 17
- 主要终点
- Mean change from baseline in best corrected visual acuity (BCVA) at month 12
研究概览
简要总结
This study is designed to assess safety and efficacy of intravitreal injection of Conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients sign informed consent, and are willing and able to comply with all the follow-ups;
- •Age ≥ 18 years , both genders;
- •Diagnosis of type 1 or type 2 diabetes mellitus;
- •Serum HbA1c ≤ 10%;
- •Study eye must meet the following criteria:
- •Visual acuity impairment caused by DME with involving foveal;
- •BCVA score ≥ 24 and ≤ 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 meter/1 meter of ETDRS test(Equivalent Snellen chart 20/40 to 20/320);
- •Visual impairment due to Choroidal Neovascularization (CNV) secondary to high myopia.
- •Central retinal thickness (CRT) ≥300μm (spectral domain Optical Coherence Tomography (OCT), the CRT measurements must be confirmed by central reading center);
- •Refractive media opacities and miosis have no effect on the fundus examination.
- •Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).
排除标准
- •Active infectious ocular inflammation in either eye;
- •Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR;
- •Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy;
- •Iris neovascularization in the study eye;
- •Uncontrolled glaucoma, or history of glaucoma surgery;
- •Aphakia in the study eye;
- •History of vitrectomy in the study eye;
- •History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to the screening, or possibly need panretinal photocoagulation of the study eye during the study;
- •Liver, kidney dysfunction;
- •History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.
研究组 & 干预措施
Conbercept treatment group
Conbercept injection and sham laser treatment at day 0 for 1st time, the investigators will decide whether the subjects need to get repeated treatment according to monthly assessment.
干预措施: Conbercept (Drug)
Conbercept treatment group
Conbercept injection and sham laser treatment at day 0 for 1st time, the investigators will decide whether the subjects need to get repeated treatment according to monthly assessment.
干预措施: Sham laser (Other)
Laser treatment group
Laser treatment and sham injection at day 0 for 1st time, the investigators will decide whether the repeated laser treatment is needed according to monthly results during the visit after 3 months.
干预措施: Sham injection (Other)
Laser treatment group
Laser treatment and sham injection at day 0 for 1st time, the investigators will decide whether the repeated laser treatment is needed according to monthly results during the visit after 3 months.
干预措施: Laser (Procedure)
结局指标
主要结局
Mean change from baseline in best corrected visual acuity (BCVA) at month 12
时间窗: Baseline and month 12
To compare mean change from baseline BCVA between treatment group and controlled group at month 12.
次要结局
- Mean change from baseline in central retinal thickness (CRT) between two groups(Baseline and month 12)
- Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection(12 months)