Brolucizumab Switch and Extend Ph IIIb Study: A Canadian, Multi-center, Single-arm, Open Label Study Assessing the Efficacy and Safety of Brolucizumab 6mg in a Treat and Extend Regimen in Patients With Neovascular Age-Related Macular Degeneration (nAMD) With Prior Anti-VEGF Exposure (PEREGRINE)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- The proportion (%) of patients switched from aflibercept 2 mg to brolucizumab 6mg that were able to successfully extend their dosing interval at week 52 without incurring disease activity after switching
研究概览
简要总结
The purpose of this study is to assess whether switching nAMD patients from aflibercept to brolucizumab would permit extension of treatment intervals while maintaining treatment efficacy, thereby alleviating the treatment burden on patients, caregivers, healthcare professionals (HCPs), and medical institutions.
详细描述
This study is a 104 week, single-arm, open label, Ph IIIb multicenter study in Canadian nAMD patients who will be switched from aflibercept 2mg to brolucizumab 6mg and extended using a Treat & Extend regimen by up to 2 week intervals assessing the durability, effectiveness, and safety of brolucizumab 6mg.
During the baseline visit, patients who consent will undergo an assessment to evaluate their eligibility based on the inclusion and exclusion criteria. Patients that meet all of the inclusion criteria and none of the exclusion criteria will be eligible to participate. The study is expected to recruit 423 patients.
If both eyes are eligible as per the inclusion and exclusion criteria, the eye with worse visual acuity should be selected for the study eye, unless the investigator deems it more appropriate to select the eye with better visual acuity.
nAMD patients stable on aflibercept q6w, q8w, q10w or q12w, will be switched to brolucizumab 6mg intravitreal injections. Disease stability is characterized by no disease activity based on the disease activity assessment (DAA) criteria (defined below) and on the investigator's judgment of visual function and/or anatomic outcomes (e.g. no change in visual acuity) or any other signs of the disease (e.g. SRF, hemorrhage, leakage, etc.).
At baseline patients will be treated with brolucizumab 6mg in the study eye only and will be scheduled for the next treatment at the pre-baseline dosing interval.
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
- •Written informed consent must be obtained personally or by a legal proxy before any assessment is performed.
- •Patients who are ≥ 50 years of age
- •Confirmed diagnosis of nAMD in the judgement of the investigator
- •Patients currently being treated with intravitreal injections of aflibercept 2 mg on 6-12 week dosing intervals for nAMD for a period no longer than 24 months from date of diagnosis.
- •Documentation of at least one attempt to extend past the current dosing interval of aflibercept 2mg and return to stable condition at the current predefined interval
- •BCVA score must be ≤ 78 (20/32) and ≥24 (20/320) letters using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity charts at baseline
排除标准
- •nAMD patients with disease activity at baseline
- •Concomitant conditions or ocular disorders in the study eye at baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period.
- •Simultaneous participation in a study that includes administration of any investigational drug or procedure, other than brolucizumab.
- •Any active intraocular or periocular infection or active intraocular inflammation, at baseline (study eye) or in the preceding 6 months
- •Uncontrolled glaucoma defined as intraocular pressure > 25 mmHg on medication, or according to investigator's judgment, at baseline (study eye)
- •Patient having a fellow eye with BCVA < 20/200 at baseline due to any causes (except when due to conditions that can lead to improved VA after surgery, e.g. cataract)
- •Patients who have been previously treated with brolucizumab in either eye, or who are currently receiving brolucizumab treatment in the fellow eye
- •Patients who have been treated with aflibercept longer than 24 months.
- •Previous use of intraocular or periocular steroids within the 6-months prior to baseline (study eye)
- •Macular laser photocoagulation (focal/grid) or photodynamic therapy (PDT) at any time prior to baseline and peripheral laser photocoagulation within 3 months prior to baseline (study eye)
- •Intraocular surgery within 3 months prior to baseline (except cataract; study eye) Vitreoretinal surgery at any time prior to baseline (study eye)
研究组 & 干预措施
brolucizumab 6mg
Open label, brolucizumab 6mg, daily dosing, Treat & Extend regimen by up to 2 week intervals. Dosing intervals as per previous therapy and treatment extension intervals
干预措施: brolucizumab (Drug)
结局指标
主要结局
The proportion (%) of patients switched from aflibercept 2 mg to brolucizumab 6mg that were able to successfully extend their dosing interval at week 52 without incurring disease activity after switching
时间窗: 104 weeks
To evaluate if Neovascular Age-related Macular Degeneration (nAMD) patients can extend treatment intervals after switching from 2mg aflibercept to 6mg brolucizumab, while maintaining treatment effectiveness
次要结局
- The % of patients switched from aflibercept 2 mg to brolucizumab 6mg that were able to maintain or extend their dosing interval at week 52 and 104(up to 104 weeks)
- The % of patients switched from aflibercept 2 mg to brolucizumab 6mg that were able to extend their dosing interval at week 104(up to 104 weeks)
- Mean change from baseline in central subfield foveal thickness (CSFT)(at weeks 52, 104)
- Mean interval (number of weeks) of patients after switch reached at any given time point at week 52 and 104(up to 104 weeks)
- Incidence of ocular (e.g., intraocular infection) and non-ocular adverse events, vital signs up to week 52, and 104(up to 104 weeks)
- The % of patients with pigment epithelial detachment (PED)(at baseline, weeks 52, 104)
- Mean maximum interval (number of weeks) of patients at week 104(Up to 104 weeks)
- Mean change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (EDTRS letters) from baseline to week 52, and 104(up to 104 weeks)
- The % of patients with a change in BCVA (EDTRS letters) of 5, 10, 15 letters or more from baseline to week 52, and 104(up to 104 weeks)
- The % of patients with any intraretinal fluid (IRF) and/or subretinal fluid (SRF) at baseline, weeks 52, and 104(up to 104 weeks)