A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 3 months versus baseline.
研究概览
简要总结
This is a multicenter, randomized, double-blind, active-controlled, parallel group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients with Neovascular(wet) Age related Macular Degeneration
详细描述
Subjects will be randomised in a 1:1 ratio to receive either CKD-701 or Lucentis®. Investigational Products (IP) (CKD-701 or Lucentis®) will be administered once a month during the loading phase(the first three months), and for the next nine months(PRN phase), administion will be determined based on the PRN administration criteria.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years
- •Presence in the study eye of active subfoveal CNV lesion due to AMD
- •The total lesion size ≤ 12 DA in the study eye
- •The presence of CNV foci of more than 50% of the total lesion area in the study eye
- •The best-corrected visual acuity within a range from 78 to 34 letters (20/32~20/200) measured using the ETDRS chart in the study eye
- •Written informed consent
排除标准
- •Any previous anti-vascular endothelial growth factor(anti-VEGF) treatment to treat neovascular AMD
- •Presence of eye-related inflammation or infection, such as Infectious ophthalmitis, corneal inflammation, conjunctivitis (including scleromalacia), endocular inflammation
- •Any history or clinical basis of disease affecting the retina except age-related macular degeneration(AMD), such as diabetic retinopathy, diabetic macular edema
- •Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, angioid streaks retinopathy or pathologic myopia
- •Patients with macular abnormalities other than age-related macular degeneration (AMD)
研究组 & 干预措施
CKD-701
Drug: CKD-701 (proposed ranibizumab biosimilar)
干预措施: CKD-701 (Drug)
Lucentis®
Drug: Lucentis® (ranibizumab)
干预措施: Lucentis® (Drug)
结局指标
主要结局
The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 3 months versus baseline.
时间窗: Baseline to 3 months
次要结局
- The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 6 months, 12 months versus baseline(Baseline, 6 months, 12 months)
- The proportion of patients with an increase in the best-corrected visual acuity (BCVA) score of 15 or more letters at 3 months, 6 months, 12months versus baseline(Baseline, 3 months, 6 months, 12 months)
- Mean change in the best-corrected visual acuity (BCVA) score from baseline to 3 months, 6 months and 12 months(Baseline, 3 months, 6 months, 12 months)
- Change in the Central Retinal Thickness(CRT) at 1 months, 3 months, 6 months, 12months versus baseline(Baseline, 1 months, 3 months, 6 months, 12 months)
- The proportion of patients with the absence of intraretinal fluid and subretinal fluid at 3 months, 6 months, 12months versus baseline(3 months, 6 months, 12 months)