A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 With Lucentis® in Patients With Neovascular Age Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Lupin Ltd.
- 入组人数
- 600
- 试验地点
- 84
- 主要终点
- Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months
研究概览
简要总结
This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).
详细描述
This is a global, phase III, double blind, randomized controlled study to compare the efficacy, safety & immunogenicity of LUBT010 with Lucentis® in patients with neovascular age-related macular degeneration.
Eligible patients will be randomly assigned in 1:1 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis® for 12 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory male or female participants with age ≥ 50 years at the time of screening
- •Capable of understanding and giving written informed consent
- •Primary or recurrent (anti-vascular endothelial growth factor naïve) active choroidal neovascularization (CNV) lesions involving the foveal center secondary to AMD
- •Best corrected visual acuity (BCVA) between 20/40 and 20/200 (Snellen equivalent) in the study eye, using ETDRS testing
- •Willingness and ability to undertake all scheduled visits and assessments
排除标准
- •Known hypersensitivity to ranibizumab or any of the components of study medication
- •Known history of allergy to fluorescein dye
- •Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
- •Subretinal hemorrhage in the study eye that involves the center of the fovea
- •Uncontrolled glaucoma
- •Use of prohibited treatments
- •Other In-/Exclusion criteria may apply
研究组 & 干预措施
Drug: LUBT010 (proposed ranibizumab biosimilar)
干预措施: LUBT010 (proposed ranibizumab biosimilar) (Drug)
Drug: Lucentis (ranibizumab)
干预措施: Lucentis (ranibizumab) (Drug)
结局指标
主要结局
Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months
时间窗: Baseline and 12 Months
Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement
次要结局
- Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months(Baseline and 3 Months)
- Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months(Baseline and 6 Months)
- Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months(Baseline and 9 Months)