A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
概览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 119
- 主要终点
- Change from Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Weeks 4, 8, and 12
概览
简要总结
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).
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
- 18 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 myopia
- •Diagnosis of active myopic CNV in the study eye:
- •Presence of high myopia, worse than -6 diopters of spherical equivalence
- •Antero-posterior elongation measurement greater than or equal to 26.0 mm
- •Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.)
- •Presence of active leakage from CNV on FFA (determined by Central Reading Centre \[CRC\])
- •Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)
- •BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1
- •Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
- •Ability to comply with the study protocol, in the Investigator's judgment
排除标准
- •Any major illness or major surgical procedure within 1 month before screening
- •Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration
- •Uncontrolled blood pressure (systolic \>180 millimetres of mercury \[mmHg\], diastolic \>100 mmHg)
- •Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
- •History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator
- •Uncontrolled glaucoma in study eye
- •Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye
- •Prior or concomitant periocular or intravitreal pharmacological treatment, including anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME etc.) in study eye
- •Other protocol-defined exclusion criteria apply
研究组 & 干预措施
Arm A: Faricimab
All participants randomly assigned to Arm A will receive faricimab 6 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with faricimab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.
干预措施: Faricimab (Drug)
Arm A: Faricimab
All participants randomly assigned to Arm A will receive faricimab 6 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with faricimab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.
干预措施: Sham Procedure (Procedure)
Arm B: Ranibizumab
All participants randomly assigned to Arm B will receive ranibizumab 0.5 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with ranibizumab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.
干预措施: Ranibizumab (Drug)
Arm B: Ranibizumab
All participants randomly assigned to Arm B will receive ranibizumab 0.5 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with ranibizumab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.
干预措施: Sham Procedure (Procedure)
结局指标
主要结局
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Weeks 4, 8, and 12
时间窗: Baseline and Average of Weeks 4, 8, and 12
次要结局
- Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48(From Baseline to Weeks 12, 24, and 48)
- Change from Baseline in Central Subfield Thickness (CST) of the Study Eye Averaged Over Weeks 4, 8, and 12(Baseline and Average of Weeks 4, 8, and 12)
- Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time(From Baseline through Week 48)
- Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time(From Baseline through Week 48)
- Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48(From Baseline to Weeks 12, 24, and 48)
- Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline or Achieving a BCVA of ≥84 Letters Over Time(From Baseline through Week 48)
- Change from Baseline in BCVA Over Time(From Baseline through Week 48)
- Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Averaged Over Weeks 4, 8, and 12(Baseline and Average of Weeks 4, 8, and 12)
- Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48(Baseline, Weeks 12 and 48)
- Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48(Baseline, Weeks 12 and 48)
- Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time(From Baseline through Week 48)
- Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time(From Baseline through Week 48)
- Change from Baseline in CST of the Study Eye Over Time(From Baseline through Week 48)
- Incidence and Severity of Ocular Adverse Events(From first dose until 35 days after the last dose of study treatment (up to 48 weeks))
- Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48(Weeks 12 and 48)
- Incidence and Severity of Non-Ocular Adverse Events(From first dose until 35 days after the last dose of study treatment (up to 48 weeks))
- Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study(At Baseline and from first dose until end of study (up to 48 weeks))