A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 146
- 主要终点
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
研究概览
简要总结
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.
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
- •Diagnosis of diabetes mellitus (Type 1 or Type 2)
- •Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
- •Decreased visual acuity attributable primarily to DME
- •Ability and willingness to provide written informed consent and to comply with the study protocol
- •Willingness to allow Aqueous Humor collection
- •For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of <1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment
排除标准
- •Hemoglobin A1c (HbA1c) of greater than (>) 12%
- •Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- •Currently pregnant or breastfeeding, or intend to become pregnant during the study
- •Prior treatment with panretinal photocoagulation or macular laser to the study eye
- •Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
- •Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
- •Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
- •Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: </=24 weeks prior to Day 1) in either eye
- •Any proliferative diabetic retinopathy
- •Active intraocular or periocular infection or active intraocular inflammation in the study eye
- •Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- •Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
- •Other protocol-specified inclusion/exclusion criteria may apply
研究组 & 干预措施
Arm A: 0.25 mg Vamikibart Q8W
Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
干预措施: Sham Procedure (Other)
Arm B: 1.0 mg Vamikibart Q8W
Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
干预措施: Sham Procedure (Other)
Arm A: 0.25 mg Vamikibart Q8W
Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
干预措施: Vamikibart (Drug)
Arm B: 1.0 mg Vamikibart Q8W
Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
干预措施: Vamikibart (Drug)
Arm C: 1.0 mg Vamikibart Q4W
Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections.
干预措施: Vamikibart (Drug)
Arm D: 0.5 mg Ranibizumab Q4W
Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
时间窗: Baseline, Week 44 and Week 48
次要结局
- Change From Baseline in CST at Week 36(Baseline, Week 36)
- Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population(Baseline, Week 44 and Week 48)
- Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants(Baseline, Week 20 and Week 24)
- Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants(Baseline, Week 32 and Week 36)
- Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time(From baseline up to end of study (up to Week 72))
- Number of Participants With Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters(Up to Week 72)
- Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants(Baseline, Week 20 and Week 24)
- Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time(From baseline up to end of study (up to Week 72))
- Change From Baseline in Central Subfield Thickness (CST) at Week 48(Baseline, Week 48)
- Number of Participants With Abnormalities in Standard Ophthalmological Assessments(Up to Week 72)
- Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants(Baseline, Week 44 and Week 48)
- Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time(From baseline up to end of study (up to Week 72))
- Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent), or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time(From baseline up to end of study (up to Week 72))
- Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population(Baseline, Week 20 and Week 24)
- Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants(Baseline, Week 32 and Week 36)
- Change From Baseline in BCVA Over Time(From baseline up to end of study (up to Week 72))
- Change From Baseline in CST at Week 24(Baseline, Week 24)
- Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time(From baseline up to end of study (up to Week 72))
- Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population(Baseline, Week 32 and Week 36)
- Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time(From baseline up to end of study (up to Week 72))
- Change From Baseline in CST Over Time(From baseline up to end of study (up to Week 72))
- Number of Participants With Systemic and Ocular Adverse Events (AEs)(Up to Week 72)