Development of New Geographic Atrophy in Patients With Neovascular (Wet) Age-related Macular Degeneration: a Comparison of Ranibizumab and Aflibercept
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24
研究概览
简要总结
The purpose of this study was to compare the development of new geographic atrophy in patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result in the progressive and irreversible loss of visual function over time.
详细描述
In each arm, patients underwent three monthly loading doses (at Baseline, Week 4, and Week 8). From Week 8, after the patient had received their third injection of study treatment, the visit intervals were determined by the patient's disease activity. If any of the protocol-specified signs of disease activity were present in the study eye, the subsequent injection visit interval was kept at 4 weeks. If none of the signs were present, the subsequent injection interval was extended by 2-week increments up until a maximum of 12-weekly intervals was reached. If there were any signs of disease activity in the study eye, the treatment interval was reduced as specified in the protocol. The planned individual duration of study participation was 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Investigators were not masked. The patients, the BCVA assessors, and the Central Reading Center (who set the treatment intervals) were masked.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ranibizumab 0.5 mg
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
干预措施: Ranibizumab 0.5 mg (Drug)
Aflibercept 2.0 mg
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity [treat and extend]
干预措施: Aflibercept 2.0 mg (Drug)
结局指标
主要结局
Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24
时间窗: Baseline, Month 24
Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.
次要结局
- Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12(Baseline, Month 12)
- Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24(Baseline, Month 12, Month 24)
- Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF)(Month 2, Month 12, Month 24)
- Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study(Baseline, Month 12, Month 24)
- Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24(Baseline, Month 12, Month 24)
- Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24(Baseline, Month 12, Month 24)
- Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells(Baseline, Week 9)
- Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24(Baseline, Month 12, Month 24)
- Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24(Baseline, Month 12, Month 24)
- Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24(Baseline, Month 12, Month 24)
- Mean Number of Times a Patient Needed to Return to Monthly Intravitreal Injections Over 24 Months(Month 24)
- Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment(Baseline, Week 5, Week 9)
- Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare(Baseline, Week 9)