Wet Macular Degeneration
Conditions
Keywords
Age-related macular degeneration, Caregiver burden, Anti-vascular endothelial growth factor (VEGF) therapy
Brief summary
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.
Interventions
DRUGAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF therapy following the Summary of Product Characteristics
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* \[Patients\] * 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
Exclusion criteria
* \[Patients\] * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of caregiving burden on caregivers (BIC-11) | 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. |
| Relationship between BIC-11 and the number of hospital visits for wAMD treatments | Up to 1 year | — |
| Frequency of hospital visits | Up to 1 year | — |
| Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes) | Up to 1 year | — |
| Estimated costs spent by accompanying caregivers on hospital visits for wAMD management | Up to 1 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosing schedule | At baseline | The schedule of doses of a therapeutic agent per unit of time |
| Percentage of patients accompanied by primary caregivers | At baseline | — |
| Level of depression among caregivers (CES-D) | At Enrollment | CES-D will be applied to determine depression.The score range is from 0 to 60, with high score indicating greater depressive symptoms. Cut off score is 16 or greater in Japan to assess whether individuals experience depression. |
| Types of treatments for wAMD | At Baseline | Anti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc. |
| Frequency of treatments | At baseline | Number of a therapeutic agent given to patients |
| Length of treatment | At baseline | Duration of a therapeutic agent received |
Countries
Japan
Outcome results
None listed