A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye
研究概览
简要总结
The purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective was to assess brolucizumab's potential for long durability up to 20 weeks.
All eligible participants were treated with brolucizumab regardless of their treatment in the TALON study.
The study period was 56 weeks including post-treatment follow-up.
详细描述
This was a 56-week, open-label, one-arm extension study in subjects who had completed the CRTH258A2303 (TALON) (NCT04005352) study, referred to as the core study in this document. Subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (TtC) regimen, irrespective of the treatment received in the core study.
The maximum study duration for a subject was 56 weeks, including post-treatment follow-up.
There were two periods in this study:
- Treat-to-Control treatment period: from Baseline (Day 1) to Week 52
- Post-treatment follow-up period: from Week 52 to Week 56.
All participants were treated with brolucizumab regardless of their treatment in the TALON study (brolucizumab or aflibercept).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed informed consent
- •Successfully completed TALON core study at week 64 (End of Study)
排除标准
- •Medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
- •Discontinued study treatment in the core study
- •Anti-VEGF treatment is futile in the study eye, in the Investigator's opinion.
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential not using highly effective methods of contraception
研究组 & 干预措施
brolucizumab 6 mg
Participants received brolucizumab 6 mg/0.05 mL solution by intravitreal injection in a Treat-to-Control regimen with injection intervals from 4 up to 20 weeks. Intervals could have changed in steps of 4 weeks at a time per investigators' decisions determined by the disease activity.
干预措施: brolucizumab (Drug)
结局指标
主要结局
Duration of the Last Interval With no Disease Activity up to Week 56 - Study Eye
时间窗: Up to Week 56
Number of subjects in every 4 weeks (q4w), every 8 weeks (q8w), every 12 weeks (q12w) and every 20 weeks (q20w) intervals at last interval with no disease activity up to Week 56. Last interval with no disease activity (number of weeks): Number of subjects at 20/16/12/8/4-weeks intervals up to Week 56 for the study eye in the extension study
Average Change in BCVA From Baseline to Week 52 and Week 56 for the Study Eye
时间窗: Extension study baseline, average of Week 52 and Week 56
Best-Corrected Visual Acuity (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. The average change in BCVA from Baseline of the extension study at Week 52 and Week 56 was estimated by an analysis of variance (ANOVA) with baseline age categories, baseline BCVA categories and treatment arm in the core study included as fixed effects. Last observation carried forward (LOCF) was used to impute missing BCVA values.
次要结局
- Number (%) of Subjects With Change in Duration of Last Interval With no Disease Activity Between Baseline of the Extension Study and Week 56 by Core Study Treatment Arm(Extension study baseline, up to Week 56)
- Number (%) of Subjects With Presence of IRF and/or SRF, and Sub-RPE Fluid in the Study Eye at Week 52 and Week 56 Overall and by Core Study Treatment Arm(Weeks 52 and 56)
- Treatment-emergent Ocular Adverse Events (Greater Than or Equal to 1.0%) by Preferred Term for the Study Eye(Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.)
- Average Change in Central Subfield Thickness (CSFT) From Baseline to Week 52 and Week 56 - Study Eye(Extension study baseline, average of Week 52 and Week 56)
- Last Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study by Core Study Randomized Treatment Arm(up to Week 56)
- Maximal Interval With no Disease Activity (Number of Weeks): Number (%) of Subjects at 20/16/12/8/4-weeks Intervals up to Week 56 for the Study Eye in the Extension Study(up to Week 56)
- Treatment-emergent Non-ocular Adverse Events (Greater Than or Equal to 2%) by Preferred Term(Adverse events are reported from the first dose of study-drug until the end of treatment at week 52, plus 4 weeks safety follow-up, for a maximum timeframe of approximately 56 weeks.)