NCT05345236已完成3 期
A Phase III Randomised, Double-masked, Parallel Group Study to Compare the Efficacy and Safety Between QL1207 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Wet Age-related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12
研究概览
简要总结
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of QL1207 compared to Eylea® in subjects with wet AMD.
详细描述
Subjects will be randomised in a 1:1 ratio to receive either QL1207 or Eylea® (administered via intravitreal [IVT] injection 2 mg [0.05 mL] every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every 8 weeks ) . Subjects will be administered the study drug up to week 48, and the last assessment will be done at Week 52.
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
- •Age ≥ 50 years male and female
- •Treatment naïve, *active subfoveal choroidal neovascularisation (CNV) lesion secondary to AMD in the study eye
- •CNV area ≥50% of total lesion size
- •Total lesion area ≤ 12.0 Disc Areas (DA) in size (including blood, scars, and neovascularisation) in the study eye
- •BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using ETDRS charts in the study eye
- •Fellow eye is not expected to need any anti-VEGF treatment for the duration of study participation.
排除标准
- •Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea
- •Scar, fibrosis, or atrophy involving the centre of the fovea
- •Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia
- •Any concurrent macular abnormality other than AMD which could affect central vision or the efficacy of IP
- •Current vitreous haemorrhage within 30days before randomization
- •Any other intraocular surgery or periocular surgery within 90 days prior to randomisation, except for lid surgery, which may not have taken place within 30 days prior to randomisation.
- •Uncontrolled ocular hypertension (defined as intraocular pressure [IOP] ≥ 25 mmHg despite treatment with anti-glaucoma medication) at Screening
- •Either eye:
- •Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment
- •Any previous systemic anti-VEGF treatment
- •History of treatment involving macula such as macular laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, or any ocular treatment for neovascular AMD
- •Active or suspected ocular and periocular infection at Screening or at randomisation
- •History of idiopathic or autoimmune-associated uveitis
- •Known allergic reactions and/or hypersensitivity to any component of Eylea or QL1207 or allergy to the fluorescein sodium for injection in angiography
- •Uncontrolled systemic hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 95 mmHg on optimal medical regimen)
- •Any previous systemic anti-VEGF treatment
- •Women of childbearing potential who are pregnant, planning to become pregnant, lactating, or not using adequate birth control, as specified in protocol. For women of childbearing potential, a serum pregnancy test must result negative at Screening.
研究组 & 干预措施
QL1207
Experimental
Subjects randomized into QL1207 group will receive QL1207 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
干预措施: Aflibercept (Drug)
Eylea®
Active Comparator
Subjects randomized into Eylea® group will receive Eylea® 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12
时间窗: Baseline (Day 0), Week 12
次要结局
- Change from baseline in CNV area from baseline to week 12, week 24 and week 52(Baseline (Day 0), Week 12, Week 24, Week 52)
- Change From Baseline in CRT(central retina thickness) by visit(Baseline (Day 0), week 4, week 8, Week 12, Week 24, Week 52)
- BCVA Change From Baseline by visit(Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52)
- Proportion of subjects who gained at least 5,10 and 15 lettersbaseline to week 12,week 24 and week 52(Baseline (Day 0), Week 12, Week 24, Week 52)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)Age-Related Macular DegenerationNCT03150589Samsung Bioepis Co., Ltd.705
已完成
3 期
A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)Neovascular Age-related Macular DegenerationNCT04450329Samsung Bioepis Co., Ltd.449
已完成
3 期
A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)Age-related Macular DegenerationNCT00891735Genentech, Inc.1,097
已完成
3 期
Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of Recombinant Anti-interleukin-6 Receptor Humanized Monoclonal Antibody Injection in Combination With Methotrexate and Jamelor ® in the Treatment of Moderate to Severe Rheumatoid ArthritisModerate to Severe Active Rheumatoid ArthritisNCT06048224Zhejiang Hisun Pharmaceutical Co. Ltd.669
已完成
4 期
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement StudyThyroid Eye DiseaseNCT05002998Amgen313