NCT04079231撤回3 期
A Comparative Double Masked, Two-Arm, Randomized, Multicenter, Phase IIIb Study Analyzing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (BUZZARD)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Mean change in BCVA from baseline to Week 48
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
详细描述
In this 48-week, randomized, double-masked, multicenter, active controlled study, consenting patients will be randomized in a 1:1 ratio to one of the two treatment arms and attend 14 planned visits.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at Screening
- •BCVA score between 23 and 65 letters, inclusive, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/50 to 20/320), at screening and baseline
- •DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of ≥ 320 µm on SD-OCT
排除标准
- •High risk or advanced proliferative diabetic retinopathy in the study eye as per reading Center
- •Active intraocular or periocular infection or active intraocular inflammation in the study eye
- •Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg)
- •Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye in the last 3 months prior randomization
- •Stroke or myocardial infarction during the 6-month period prior to baseline
- •Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg Other protocol-specified inclusion/exclusion criteria may apply
研究组 & 干预措施
Brolucizumab 6 mg
Experimental
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
干预措施: Brolucizumab (Drug)
Aflibercept 2 mg
Active Comparator
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
干预措施: Aflibercept (Drug)
结局指标
主要结局
Mean change in BCVA from baseline to Week 48
时间窗: Baseline, Week 48
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Proportion of patients with a gain in Best Corrected Visual Acurity (BCVA) of ≥15 ETDRS letters at week 48
时间窗: Week 48
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
次要结局
- Proportion of patients maintained at q12w up to Week 48(Baseline, Week 48)
- Proportion of patients with presence of SRF, IRF and simultaneous absence of SRF and IRF at each assessment visit(Baseline, Week 48)
- Proportion of patients with presence of leakage on FA at Week 48(Week 48)
- Rate of "inactive" PDRs by Week 48 compared to baseline(Baseline, Week 48)
- Proportion of patients maintained at q12w up to Week 48, within those patients that qualified for q12w at week 28(Week 28, Week 48)
- Change from baseline in Central Subfield Thickness-neurosensory (CSFTns, as determined by SD-OCT) at each assessment visit(Baseline, week 48)
- Patient status regarding a ≥2- and ≥3-step improvement or worsening from baseline in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at each assessment visit(Baseline, Week 48)
- Incidence of progression to PDR as assessed by ETDRS-DRSS score of at least 61 by Week 48(Baseline, Week 48)
- Proportion of patients with a loss in BCVA of ≥15 ETDRS letters from baseline to Week 48(Baseline, Week 48)
- Average change in CSFTns from baseline over the period Week 36 through Week 48(Baseline, Week 36, Week 48)
- Average change in CSFTns from baseline over the period Week 4 to Week 48(Baseline, Week 4, Week 48)
- Proportion of patients with a loss in BCVA of ≥10 ETDRS letters from baseline to Week 48(Baseline, Week 48)
- Change from baseline in central subfield thickness (CSFT, as determined by SD-OCT) at each assessment visit(Baseline, Week 48)
- Average change in CSFT from baseline over the period Week 36 through Week 48(Week 36, Week 48)
- Patient status regarding normal CSFT thickness (<280 microns) at each assessment visit(Baseline, Week 48)
- Change in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score up to Week 48 (central reading)(Baseline, Week 48)
- Change from baseline in BCVA averaged over a period Week 36 to Week 48(Week 36, Week 48)
- Proportion of patients with a gain in BCVA of ≥10 ETDRS letters from baseline to Week 48(Baseline, Week 48)
- Average change in CSFT from baseline over the period Week 4 to Week 48(Week 4, Week 48)
研究者
相似试验
终止
3 期
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein OcclusionCentral Retinal Vein OcclusionNCT03810313Novartis Pharmaceuticals493
终止
3 期
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein OcclusionBranch Retinal Vein OcclusionNCT03802630Novartis Pharmaceuticals450
已完成
3 期
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular EdemaDiabetic Macular EdemaNCT03481634Novartis Pharmaceuticals566
已完成
3 期
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic RetinopathyProliferative Diabetic RetinopathyNCT04278417Novartis Pharmaceuticals689
已完成
3 期
Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular EdemaDiabetic Macular EdemaNCT03917472Novartis Pharmaceuticals517