Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) Treatment in Real-life Japanese Settings.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 72
- 主要终点
- Degree of caregiving burden on caregivers (BIC-11)
研究概览
简要总结
This study aims at investigation of the caregiver burden of Wet Age-related Macular Degeneration (wAMD) patients and at the assessment of how much of caregiver burden could be reduced in transitioning from Pro Re Nata to proactive therapy especially in real-life rural settings where public transportations are not readily available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[Patients]
- •Female and male out-patients diagnosed with wAMD.
- •Patients who are accompanied by his/her caregiver(s).
- •Patients who have been receiving anti-VEGF therapy with proactive regimen for 12 months or more at the participating site.
- •Providing informed consent for the participation in this study.
- •[Caregivers]
- •Providing informed consent for the participation in this study.
- •Capable of understanding and completing the questionnaires without any help from others
排除标准
- •[Patients]
- •Presence of a disease or a condition more disabling than wAMD in term of caregiving.
- •Presence of intractable neurologic disease, physical handicap, mental handicap, or any condition that rendered them unable to walk independently.
- •Intraocular surgery for other eye diseases after the start of wAMD therapy.
- •[Caregivers]
- •Professional carers
研究组 & 干预措施
PRN group
wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN)
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
TAE group
wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE)
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
PRN-to-TAE switcher group
wAMD patients treated with anti-VEGF therapy and switching from PRN to TAE regimens
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Degree of caregiving burden on caregivers (BIC-11)
时间窗: At enrollment
Burden Index of Caregivers (BIC), a multidimensional short care burden scale from Japan.The score range is from 0-40, with high scores indicating greater care giver burden.
Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)
时间窗: Up to 1 year
Relationship between BIC-11 and the number of hospital visits for wAMD treatments
时间窗: Up to 1 year
Frequency of hospital visits
时间窗: Up to 1 year
Estimated costs spent by accompanying caregivers on hospital visits for wAMD management
时间窗: Up to 1 year
次要结局
- Level of depression among caregivers (CES-D)(At Enrollment)
- Types of treatments for wAMD(At Baseline)
- Percentage of patients accompanied by primary caregivers(At baseline)
- Frequency of treatments(At baseline)
- Length of treatment(At baseline)
- Dosing schedule(At baseline)