NCT04739306已完成3 期
A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
研究概览
简要总结
This is a Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in comparison with Eylea in Patients with Diabetic Macular Edema
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female patient aged ≥18 years.
- •Patient with DME secondary to DM involving the center of the macula (defined as the Optical Coherence Tomography [OCT] central subfield) in the study eye.
排除标准
- •Patient who has only one functional eye.
- •Patient who currently has, or has a history (where indicated) of active proliferative diabetic retinopathy
结局指标
主要结局
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
时间窗: Baseline and Week 8
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Subjects with a BCVA ETDRS letter score of 73 to 34 (= Acuity of 20/40 to 20/200) in the study eye at Screening and Day 1 were included. Visual acuity of the study eye was assessed using the ETDRS charts; a higher score represents better functioning.
次要结局
- Mean Change From Baseline in BCVA at Week 52(Baseline and Week 52)
- Proportion of Subjects With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52(Baseline and Week 52)
- Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52(Baseline and Week 52)
- Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT)(Baseline and Week 52)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®Postmenopausal OsteoporosisNCT05405725Enzene Biosciences Ltd.504
招募中
3 期
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisNCT05906992Celltrion512
已完成
3 期
Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)Branch Retinal Vein OcclusionNCT01521559Regeneron Pharmaceuticals183
已完成
3 期
A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD)Wet Age-related Macular DegenerationNCT05345236Qilu Pharmaceutical Co., Ltd.366
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic MyopiaChoroidal Neovascularization Secondary to Pathologic MyopiaNCT06176352Hoffmann-La Roche280