NCT05297292Unknown2 期
A Multicenter, Randomized, Double-blind, Positive-controlled, Seamless Design Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (Code MW02) in the Treatment of Neovascular (Wet) Age-related Macular Degeneration (nAMD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 433
- 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
The purpose of this study is to compare the efficacy and safety of MW02 versus Lucentis in the treatment of neovascular age-related macular degeneration.The study was divided into two stages. The first stage was to explore the dose and the second stage was to explore the frequency of administration.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fully understand this research and sign ICF; Willing to follow and be able to complete all study procedures;
- •Age ≥ 50 years old, < 80 years old, male or female;
- •Active CNV lesions in fovea and/or parafovea secondary to nAMD , which have not been treated in the study eye 3 months before screening;
- •The BCVA of the study eye is 73~24 letters (including boundary value), which is equivalent to 20/40 to 20/320 of Snellen's visual acuity chart.
- •CNV area of the study eye≥50% of the total lesion area.
排除标准
- •There is subretinal or intraretinal hemorrhage in the study eye, and the bleeding area is ≥ 50% of the total lesion area, or it is located in the fovea and the area is ≥ 1 optic disc area;
- •The study eye has scar, fibrosis, geographic atrophy and dense hard exudation under the fovea.
- •CNV caused by non-nAMD exists in the study eye (such as trauma, pathological myopia, multifocal choroiditis, ocular histoplasmosis, vascular stripes, etc.);
- •The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, macular epiretinal membrane, retinal pigment epithelium tear involving macular, vitreous macular traction syndrome, optic nerve disease, etc.);
- •Intravitreous hemorrhage occurred in the study eye within 30 days before the first administration.
- •The study eye has received the following intraocular surgery within 90 days, or has previously received various macular laser treatments (such as macular transposition, transpupillary thermotherapy, macular photocoagulation, vitrectomy, optic nerve incision, optic nerve sheath incision, etc.) (except those who have received Vitepofin-photodynamic therapy, cataract surgery and YAG posterior capsulotomy more than 3 months before screening) or have performed external eye surgery within 30 days;
- •The study eye has used corticosteroids in the eye or in the whole body within 3 months or injected corticosteroids around the globe within 30 days before the first administration;
- •The study eye has poorly controlled glaucoma (defined as intraocular pressure≥25 mmHg after anti-glaucoma treatment), and/or has received glaucoma filtering surgery (such as trabeculectomy, scleral bite, non-penetrating trabecular surgery, etc.);
- •The study eye has high myopia with diopter≥8D
- •The study eye has refractive interstitial turbidity and/or myosis that affect fundus or OCT examination;
- •Aphakia (except intraocular lens) or rupture of posterior capsule of lens (except YAG laser posterior capsulotomy after intraocular lens implantation more than 30 days before the first administration);
- •Scleromalacia exists in the study eye.
研究组 & 干预措施
Lucentis-0.5mg（Q4w）
Active Comparator
It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 0.5mg.
干预措施: Lucentis (Drug)
MW02-1.0mg（Q4w）
Experimental
It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.0mg.
干预措施: MW02 (Drug)
MW02-1.5mg（Q4w）
Experimental
It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.5mg.
干预措施: MW02 (Drug)
MW02（Q8w）
Experimental
It is administered once every 4 weeks for 3 consecutive times, and then once every 8 weeks for 48 weeks.
干预措施: MW02 (Drug)
结局指标
主要结局
Change from Baseline in Best Corrected Visual Acuity (BCVA)
时间窗: At week 52
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 52.
次要结局
- Change from Baseline in BCVA(baseline to week 52)
研究者
研究点 (1)
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