A Real-world, Prospective, Multi-center, Open-label, Phase IV Clinical Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
研究概览
简要总结
The purpose of this study was to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) patients that more closely resemble the real-world population intended to be treated with brolucizumab. This study was conducted as part of the post-marketing regulatory commitment to the Indian Health authority.
详细描述
The study was a prospective, multi-center, open-label, interventional phase IV clinical study.
The study treatment, i.e., brolucizumab was prescribed in terms of the marketing authorization; the assignment of the patient to the therapy was decided within the current practice and the medical indication. It was clearly separated from the decision to include the patient in the study.
All patients with Neovascular Age-related Macular Degeneration (nAMD) who were planned to be treated with brolucizumab and had provided informed consent were enrolled in the study. A total of 12 sites in India were evaluated for the study conduct. This is to note that site #03 was not selected, and site #07 was not initiated, and patients were enrolled in the study only from 10 sites.
The treatment period for each patient was 56 weeks after the start of brolucizumab treatment.
Study visits were scheduled at Week 4, Week 8, Week 16, and thereafter at intervals of 8 weeks or 12 weeks after disease activity assessment at Week 16. If the investigators required more frequent follow-up visits, it was done according to their discretion and clinical judgment. Any patient who suffered from IOI during the study period was not re-challenged with brolucizumab.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male, treatment naïve patient with ≥50 years of age, with neovascular age-related macular degeneration (nAMD).
- •Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.
- •Note: In case where both eyes are affected, data of only one eye ['study eye'] will be recorded. Selection of the eye to be considered for the purpose of the study [referred to as 'study eye'] will be as per the Investigator's discretion.
排除标准
- •Patients fulfilling any of the following criteria are not eligible for this study:
- •Patient having other eye diseases that could compromise the VA.
- •Patient with existing or suspected ocular or periocular infection in the study eye.
- •Patient with an existing intraocular inflammation (IOI).
- •Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
- •Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study.
- •Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
研究组 & 干预措施
Brolucizumab
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment.
Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing.
干预措施: Injection Brolucizumab (Biological)
结局指标
主要结局
Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
时间窗: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term
时间窗: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
时间窗: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment-emergent Adverse Events (TEAEs) in this study are defined as AEs suspected to be related to the study drug.
Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
时间窗: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
次要结局
- Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab.(Week 56)
- Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 Weeks.(Week 56)
- Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks.(Week 56)
- Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye(Week 16 and Week 56)
- Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye(Week 16 and Week 56)
- Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye(Week 16 and Week 56)
- Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye(Week 16 and Week 56)
- Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye(Baseline, Week 16 and Week 56)
- Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye(Baseline, Week 16 and Week 56)
- Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye(Baseline, Week 16, Week 56)
- Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye(Baseline, Week 16, Week 56)
- Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye(Baseline, Week 16 and Week 56)
- Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye(Baseline, Week 16 and Week 56)
- Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye(Week 56)
- Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab(Week 56)