NCT05324774Unknown3 期
Phase III Clinical Study of the Efficacy and Safety of 9MW0813 and Aflibercept (EYLEA®) in Patients With Diabetic Macular Edema (DME) in a Multicenter, Randomized, Double-blind, Parallel Active-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Change from Baseline in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
Phase III clinical study of the efficacy and safety of 9MW0813 and aflibercept (EYLEA®) in patients with diabetic macular edema (DME) in a multicenter, randomized, double-blind, parallel active-controlled study.
详细描述
This is a multi-center, randomized, double-blind, parallel controlled phase 3 clinical trial.
The primary objective is to compare the similarity of clinical efficacy of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients.
The secondary objectives are to compare the similarity of safety, immunogenicity and pharmacokinetics of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients.
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
- •Age ≥ 18 years old, gender is not limited;
- •Diagnosed with type 1 or type 2 diabetes, and HbA1c≤10.0%;
- •The visual impairment of the study eye was mainly caused by diabetic macular edema;
- •OCT examination at screening and baseline, diabetic macular edema involving the fovea of the study eye, and central retinal thickness (CRT) ≥ 300 μm (using SD-OCT);
- •The best-corrected visual acuity (BCVA) of the study eye at screening and baseline measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart was between 73 and 24 letters (inclusive) (approximately equivalent to Snellen's visual acuity) score 20/40 to 20/320).
排除标准
- •Active proliferative diabetic retinopathy (PDR) exists in the study eye;
- •Structural damage to the fovea in the study eye, which may not improve BCVA after resolution of macular edema (eg, retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia, or organizing hard exudates) );
- •The study eye has any ocular disease or past medical history other than diabetic macular edema, and the investigator believes that it may affect the macular assessment or central vision (such as: cataract, retinal vascular occlusion, retinal detachment, macular traction, macular epiretinal membrane , macular hole, macular hemorrhage, preretinal fibrous proliferation involving the macula, various choroidal neovascularization);
- •The study eye has erythema of the iris, vitreous hemorrhage or traction retinal detachment;
- •The study eye has poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma drug treatment);
- •The study eye has received or may have received glaucoma filtration surgery (such as: trabeculectomy, sclerectomy and non-penetrating trabecular surgery) during the study period;
- •The study eye has received vitreoretinal surgery in the past;
- •Aphakic (except intraocular lens) in the research eye.
研究组 & 干预措施
9MW0813
Experimental
干预措施: 9MW0813 (Drug)
aflibercept
Active Comparator
干预措施: Aflibercept (Drug)
结局指标
主要结局
Change from Baseline in Best Corrected Visual Acuity (BCVA)
时间窗: 8 weeks
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score
Change from Baseline in Central Retinal Thickness（CRT）
时间窗: 8 weeks
Change from Baseline in CRT as measured by optical coherence tomography
次要结局
- Incidence of adverse events(52 weeks)
- Immunogenicity of IVT injection of 9MW0813 and aflibercept(52 weeks)
研究者
研究点 (1)
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