NCT03823300已完成3 期
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 658
- 试验地点
- 137
- 主要终点
- Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
研究概览
简要总结
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
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, 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
- •Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
- •Ability to comply with the study protocol, in the investigator's judgment
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
- •Other protocol-specified inclusion criteria may apply
排除标准
- •Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
- •Pregnancy or breastfeeding, or intention to become pregnant during the study
- •CNV due to causes other than AMD in the study eye
- •Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
- •Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
- •Uncontrolled glaucoma in the study eye
- •Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
- •Prior IVT administration of faricimab in either eye
- •History of idiopathic or autoimmune-associated uveitis in either eye
- •Active ocular inflammation or suspected or active ocular or periocular infection in either eye
- •Other protocol-specified exclusion criteria may apply
研究组 & 干预措施
Arm A: Faricimab
Experimental
干预措施: Faricimab (Drug)
Arm A: Faricimab
Experimental
干预措施: Sham Procedure (Procedure)
Arm B: Aflibercept
Active Comparator
干预措施: Aflibercept (Drug)
Arm B: Aflibercept
Active Comparator
干预措施: Sham Procedure (Procedure)
结局指标
主要结局
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
时间窗: From Baseline through Week 48
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
次要结局
- Change From Baseline in BCVA in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60(Baseline, average of Weeks 52, 56, and 60)
- Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48(Baseline, average of Weeks 40, 44, and 48)
- Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60(From Baseline through Week 60)
- Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48(Baseline, average of Weeks 40, 44, and 48)
- Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48(Baseline, average of Weeks 40, 44, and 48)
- Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112)
- Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112(Baseline and Week 112)
- Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60(Baseline, average of Weeks 52, 56, and 60)
- Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48(Baseline, average of Weeks 40, 44, and 48)
- Number of Study Drug Injections Received in the Study Eye Through Week 48(From Baseline through Week 48)
- Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48(From Baseline through Week 48)
- Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time(Up to 112 weeks)
- Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60(Week 60)
- Number of Study Drug Injections Received in the Study Eye Through Week 60(From Baseline through Week 60)
- Number of Study Drug Injections Received in the Study Eye Through Week 108(From Baseline through Week 108)
- Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60(From Baseline through Week 60)
- Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112)
- Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48(Baseline, average of Weeks 40, 44, and 48)
- Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48(Baseline and Week 48)
- Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48(Week 48)
- Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112(Weeks 108 and 112)
- Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112)
- Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112)
- Percentage of Participants With at Least One Non-Ocular Adverse Event(From first dose of study drug through end of study (up to 112 weeks))
- Change From Baseline in Central Subfield Thickness in the Study Eye Over Time(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112)
- Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48(Baseline and Week 48)
- Plasma Concentration of Faricimab Over Time(Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112)
- Percentage of Participants With at Least One Adverse Event(From first dose of study drug through end of study (up to 112 weeks))
- Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112(Baseline and Week 112)
- Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye(From first dose of study drug through end of study (up to 112 weeks))
- Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study(Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112)
研究者
研究点 (137)
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