NCT05112835终止不适用
Brolucizumab Treatment Experience Study of Patients With Neovascular Age-related Macular Degeneration (nAMD) in UK Routine Clinical Practice (BESRA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Percentage (%) of patients with absence of retinal fluid
研究概览
简要总结
BESRA is a national, multi-center, prospective, observational study to assess the effectiveness of brolucizumab intravitreal injections in patients with nAMD treated in the UK.
详细描述
Data will be collected in a standardized manner from hospital medical records (paper and electronic) at participating centers for up to 60 months post- initiation of brolucizumab. In addition to the collection of data from medical records, retinal OCT images collected during the first two years of treatment will be transferred to a central reading center for independent grading and interpretation, in order to support the validity of anatomical measurements relevant to the primary and secondary study objectives.
Patients will be treated with brolucizumab according to routine clinical practice, independent of the study setting.
Key study design definitions:
- Index date: the date of the first brolucizumab injection.
- Index eye: the first eye to be injected with brolucizumab (analyses will be conducted for the index eye only, unless otherwise stated).
- Post-index period: time between index date and the earliest of treatment discontinuation, date of death or the date of the last recorded visit within the 60 months post-index (2-month window).
- Study period: The period between 01 September 2020 and 01 March 2027, to allow 6 months pre-index period and up to 60 months (±2 months window) follow-up for each enrolled patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of nAMD
- •≥50 years of age at index date
- •Receipt of at least one injection of brolucizumab during the eligibility period
- •Able and willing to provide signed informed consent
排除标准
- •Received treatment for retinal vein occlusion, diabetic macular edema (DME) and/or myopic choroidal neovascularization (mCNV), and/or has received a new diagnosis of diabetes-related macular degeneration in the index eye within 6 months prior to the index date
- •Receipt of anti-VEGF treatment other than brolucizumab in the index eye at index date
- •Any active intraocular or periocular infection or active intraocular inflammation in the index eye at index date
- •Has been on anti-VEGF treatment for longer than 3 years (before index date)
- •Has a contraindication and is not eligible for treatment with brolucizumab according to the Beovu® (brolucizumab) Summary of Product Characteristics (SmPC) ("Beovu 120 mg/ml solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)" 2020)
- •Any medical or psychological condition in the treating physician's opinion which may prevent the patient from participating in the study
- •Participating in a parallel interventional clinical study
- •Participating in a parallel non-interventional study (NIS) generating primary data for an anti- VEGF drug.
结局指标
主要结局
Percentage (%) of patients with absence of retinal fluid
时间窗: Month 12
Percentage (%) of patients with absence of retinal fluid (no Sub-retinal Fluid (SRF) and no Intra-retinal fluid (IRF) as documented in medical records by the treating physician in relation to OCT results)
次要结局
- Percentage (%) of patients with absence of IRF(Month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- Percentage (%) of patients with absence of retinal fluid(Month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- CRT change from baseline(Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- CST change from baseline(Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- Percentage (%) of patients with absence of PED(Month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- Percentage (%) of patients with IOI including RV and RVO(Up to 60 months)
- Percentage (%) of patients with absence of SRF(Month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- Percentage (%) of patients with absence of sub-RPE fluid(Month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- BCVA change from baseline(Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- Percentage (%) of patients with BCVA ≥70 ETDRS letters(Month 3, month 6, month 12, month 24, month 36, month 48 and month 60)
- Percentage (%) of patients with ≥3 brolucizumab injections(Month 3)
- Duration of injection intervals per patient(Up to 60 months)
- Total number of injections received(Up to 60 months)
- Percentage (%) of patients that discontinue Brolucizumab therapy(Up to 60 months)
- Percentage (%) of patients who switch from brolucizumab to another anti-VEGF(Month 12, month 24, month 36, month 48 and month 60)
- Percentage (%) of patients with disease control(Month 12 and month 24)
- Change in macular volume of IRF/SRF by central reading center(Baseline at Month 12)
研究者
研究点 (1)
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