A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Percentage of patients with absence or reduction of PED at Month 3 compared to baseline
研究概览
简要总结
This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Anonymized data of patients treated with brolucizumab intravitreal injection (IVI) who had received the first dose of brolucizumab between 01 October 2020 and 31 March 2021 was collected. Patients could either be treatment-naïve or previously treated with single or a combination of other IVI of anti-vascular endothelial growth factors (VEGFs). The primary outcome measure was the change in fluid levels (intra-retinal fluid [IRF], sub-retinal fluid [SRF], and pigment epithelial detachment [PED]) from baseline to Month 3. Secondary outcome measures included change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), number of brolucizumab injections, and safety (number of adverse events [AEs]). Descriptive statistics were tabulated for the demographic and clinical characteristics as well as outcome variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Treatment-naïve nAMD patients or patients previously treated with a single or a combination of other intravitreal anti-VEGFs
- •Patients (male or female) ≥50 years of age at the index date
- •Patients with visual acuity (VA) and optical coherence tomography (OCT) assessments at baseline and at least 1 month after initiating treatment with brolucizumab
- •Patients treated with IVI of brolucizumab (received the first dose of anti-VEGF injection during the index period [01 October 2020 to 31 March 2021])
排除标准
- •Patients with dry AMD, geographic atrophy, and other retinal diseases in the study eye
- •Patients who were part of any other nAMD trial/study during the study period
- •Patients undergoing additional ocular treatment along with other anti-VEGF agents
结局指标
主要结局
Percentage of patients with absence or reduction of PED at Month 3 compared to baseline
时间窗: From baseline to Month 3
Percentage of patients with either absence of pigment epithelial detachment (PED) at Month 3 or a reduction of PED at Month 3 compared to baseline.
Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline
时间窗: From baseline to Month 3
Percentage of patients with either absence of sub-retinal fluid (SRF) at Month 3 or a reduction of SRF at Month 3 compared to baseline.
Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline
时间窗: From baseline to Month 3
Percentage of patients with either absence of intra-retinal fluid (IRF) at Month 3 or a reduction of IRF at Month 3 compared to baseline.
次要结局
- Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR)(Baseline and Month 3)
- Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline(Baseline, Months 1 and 2)
- Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline(Baseline, Months 1 and 2)
- Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment(Months 1, 2, and 3)
- Number of patients with treatment-emergent adverse events(Baseline to Month 3)
- Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline(Baseline, Months 1 and 2)
- Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT)(Baseline, Months 1, 2, and 3)
- Number of visits during Months 1, 2, and 3 of brolucizumab treatment(Months 1, 2, and 3)
- Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment(Months 1, 2, and 3)