Ranibizumab 0.5 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea (Rising K)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Mean change from baseline in BCVA at Week 24 (±2 weeks)
研究概览
简要总结
This study was a multicenter, non-interventional, retrospective chart review of patients with DME who received ranibizumab 0.5 mg as initial intensive treatment in real-world clinical setting in Korea.
Enrolled patients started receiving ranibizumab between 01 December 2019 and 31 October 2020, with records of receiving at least 3 doses in the first 4 months after starting treatment in the data collected until 30 April 2021. Subsequent dosing interval was determined by the treating physician based on the patient's condition. Data were collected for up to 24 weeks (±2 weeks) from the date of first dose of ranibizumab, including best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) results at Week 24. Subjects were identified by review of patient medical records, and those who met the inclusion/exclusion criteria were enrolled.
The primary objective of this study was to evaluate the effectiveness of ranibizumab in patients with DME who received initial intensive treatment by analyzing the mean change in BCVA using data collected during the 24-week follow-up period. Central subfield thickness (CST), intra-retinal fluid (IRF), sub-retinal fluid (SRF), edema improvement, and Diabetic Retinopathy Severity Scale (DRSS) results were also assessed to further analyze the effectiveness of ranibizumab. The total number of ranibizumab doses administered was obtained to determine the pattern of ranibizumab treatment in real-world clinical setting.
All decisions regarding the clinical management and treatment of patients were made by the treating physician according to real-world routine practice, independently of the study. All data collected in this study were extracted from the patient medical records recorded in the process.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean change from baseline in BCVA at Week 24 (±2 weeks)
时间窗: Baseline and Week 24 (±2 weeks)
次要结局
- Mean change from baseline in CST at Week 24(Baseline and Week 24)
- Mean change from baseline in BCVA at Week 24 according to the IRF or SRF status change(Baseline and Week 24)
- Percent change in SRF status from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy(Baseline and Week 24)
- Percentage of patients with ≥5-, ≥10- and ≥15-letter gains from baseline to Week 24(Baseline and Week 24)
- Percentage of patients with improved edema from baseline to Week 24(Baseline and Week 24)
- Percentage of patients with ≥2-step DRSS improvement from baseline to Week 24(Baseline and Week 24)
- Percentage of patients with ≥2-step DRSS worsening from baseline to Week 24(Baseline and Week 24)
- Change from baseline in BCVA at Week 24 according to the IRF status change for patients with and without prior history of anti-VEGF therapy change(Baseline and Week 24)
- Change from baseline in BCVA at Week 24 according to the SRF status change for patients with and without prior history of anti-VEGF therapy change(Baseline and Week 24)
- Total number of ranibizumab doses administered during the 24-week follow-up for patients with and without prior history of anti-VEGF therapy(24 weeks)
- Mean change from baseline in BCVA at Week 24 according to the quartile of CST change(Baseline and Week 24)
- Percentage of patients with ≥5-, ≥10- and ≥15-letter gains from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy(Baseline and Week 24)
- Change from baseline in BCVA at Week 24 according to the quartile of CST change for patients with and without prior history of anti-VEGF therapy(Baseline and Week 24)
- Total number of ranibizumab doses administered during the 24-week follow-up period(24 weeks)
- Change from baseline in BCVA at Week 24 for patients with and without prior history of anti-VEGF therapy(Baseline and Week 24)
- Change from baseline in CST at Week 24 for patients with and without prior history of anti-VEGF therapy(Baseline and Week 24)
- Percent change in IRF status from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy(Baseline and Week 24)
- Percentage of patients with ≥2-step DRSS improvement and worsening from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy(Baseline and Week 24)
- Percent change in IRF or SRF status from baseline to Week 24(Baseline and Week 24)
- Percentage of patients with ≥15 and ≥30 improvement in CST from baseline to Week 24 for patients with and without prior history of anti-VEGF therapy(Baseline and Week 24)