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临床试验/NCT04058067
NCT04058067已完成3 期

A One-Year, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2019年8月23日最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
263
试验地点
1
主要终点
Change From Baseline at Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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 Chinese patients with visual impairment due to Diabetic Macular Edema.

详细描述

The study is a randomized, double-masked, multi-center, active-controlled, 2-arm study in Chinese patients with Diabetic macular edema (DME). Approximately 335 Chinese patients were planned to be screened (20% screening failure rate expected) and approximately 268 (134 per arm) patients were planned to be randomized in approximately 25 centers.

Patients who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of two treatment arms:

  • Brolucizumab 6 mg: 5 × every 6 weeks (q6w) loading then every 12 weeks (q12w) or every 8 weeks (q8w) maintenance
  • Aflibercept 2 mg: 5 × every 4 weeks (q4w) loading then q8w maintenance

Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Weeks 32, 36, and 48. In the brolucizumab arm, subjects who qualified for q12w during this initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at the subsequent DAA visit at Week 48, in which case subjects were switched to a q8w treatment interval until 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
18 Years 至 —（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
  • •Visual impairment due to Diabetic Macular Edema

排除标准

  • •Any active intraocular or periocular infection or active intraocular inflammation
  • •Structural damage of the fovea
  • •Uncontrolled glaucoma
  • •Neovascularization of the iris
  • •Other protocol-defined inclusion/exclusion criteria may apply.

研究组 & 干预措施

Brolucizumab 6 mg

Experimental

5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance

干预措施: Brolucizumab (Drug)

Aflibercept 2 mg

Active Comparator

5 x every 4 weeks loading then every 8 weeks maintenance

干预措施: Aflibercept (Drug)

结局指标

主要结局

Change From Baseline at Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye.

时间窗: Baseline to Week 52

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.

Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 40 Through Week 52 for the Study Eye

时间窗: Week 40 to Week 52

BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.

次要结局

  • Change From Baseline by Visit up to Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye(Baseline, Week 52)
  • Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 4 Through Week 52 for the Study Eye(Week 4 to Week 52)
  • Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 20 Through Week 52 for the Study Eye(Week 20 to Week 52)
  • Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 28 Through Week 52 for the Study Eye(Week 28 to Week 52)
  • Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit(Baseline (Week 0), Week 32, Week 36 and Week 48)
  • Time-to-first q8w Treatment Need: Summary for Brolucizumab Subjects by Disease Activity Assessment Visit, Within Those Subjects With no q8w-need During the Initial q12w Cycle(Week 36 and Week 48)
  • Number and Percentage of Patients Who Gained in ≥5, ≥10 and ≥15 ETDRS Letters in BCVA From Baseline to Week 52 for the Study Eye(Baseline, Week 52)
  • Time to Achieve Gain of >= 5 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain(Baseline up to Week 52)
  • Time to Achieve Gain of >= 10 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain(Baseline up to Week 52)
  • Time to Achieve Gain of >= 15 Letters in BCVA From Baseline or Reach BCVA >=84 Letters for the Study Eye - Probability of BCVA Gain(Baseline up to Week 52)
  • Number and Percentage of Patients Who Lost ≥5, ≥10 and ≥15 ETDRS Letters in BCVA From Baseline to Week 52 for the Study Eye(Baseline, Week 52)
  • Proportion of Patients Who Have Absolute BCVA ≥73 ETDRS Letters at Each Post-baseline Visit for the Study Eye(Baseline up to Week 52)
  • Number (%) of Subjects With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit - Week 32(Week 32)
  • Number (%) of Subjects With q8w Treatment Need as Assessed by the Investigator at Week 36, and Week 48(Week 36, Week 48)
  • Change From Baseline at Week 52 in Central Subfield Thickness (CSFT) for the Study Eye(Baseline, Week 52)
  • Average Change From Baseline Over the Period Week 40 Through Week 52 in Central Subfield Thickness (CSFT) for the Study Eye(Baseline, over the period of Week 40 to Week 52)
  • Average Change From Baseline Over the Period Week 4 Through Week 52 in Central Subfield Thickness (CSFT) for the Study Eye(Baseline, over the period of Week 4 to Week 52)
  • Number and Percentage of Patients Who Have CSFT (<280 Microns) at Each Assessment Visit for the Study Eye(Baseline up to Week 52)
  • Number (%) of Patients With Progression to Proliferative Diabetic Retinopathy (PDR) as Assessed by ETDRS DRSS of at Least 61 by Week 52 for the Study Eye Among the Subset of Non-PDR Subjects at Screening(Baseline, Week 52)
  • Number (%) of Patients With Presence of Leakage in the Study Eye on Fluorescein Angiography (FA)(Week 52)
  • Number (%) of Patients With Presence of Subretinal Fluid (SRF), Intraretinal Fluid (IRF) in the Study Eye(Baseline up to Week 52)
  • Number of Patients With Presence of Subretinal Fluid (SRF) in the Study at Each Assessment Visit(Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Number of Patients With Presence of Intraretinal Fluid (IRF) in the Study at Each Assessment Visit(Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Intraretinal Fluid (IRF) Status in the Central Subfield: Proportion of Subjects With Presence of IRF in the Study Eye by Visit(Week 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52)
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects(Baseline, Week 28 and Week 52)
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates(Baseline, Week 28 and Week 52)
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects(Baseline, Week 28 and Week 52)
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates(Baseline, Week 28 and Week 52)
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects(Baseline, Week 28 and Week 52)
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates(Baseline, Week 28 and Week 52)
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects(Baseline, Week 28 and Week 52)
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Worsening From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Overall Score(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - General Vision(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Near Activities(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Mental Health(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Dependency(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Driving(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Color Vision(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision(Baseline, Week 28 and Week 52)
  • Change From Baseline at Week 28 and Week 52 in Patient Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating(Baseline, Week 28 and Week 52)
  • Brolucizumab Serum Concentration(Approximately 24 hours post Day 1 treatment and approximately 24 hours post Week 24 treatment)
  • Number (%) of Patients Who Have Positive Anti-drug Antibody (ADA) Status in Brolucizumab Arm(Up to Week 52)
  • Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye(Adverse events are reported from first dose of study treatment until end of study treatment plus 30days post treatment, up to a maximum duration of approximately 52 weeks.)
  • Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm)(Adverse events are reported from first dose of study treatment until end of study treatment plus 30days post treatment, up to a maximum duration of approximately 52 weeks.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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