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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRN group | wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN) |
| |
| TAE group | wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE) |
| |
| PRN-to-TAE switcher group | wAMD patients treated with anti-VEGF therapy and switching from PRN to TAE regimens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Anti-VEGF therapy following the Summary of Product Characteristics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of caregiving burden on caregivers (BIC-11) | 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. | At enrollment |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Level of depression among caregivers (CES-D) | 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. | At Enrollment |
| Types of treatments for wAMD |
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Inclusion Criteria:
[Patients]
[Caregivers]
Exclusion Criteria:
[Patients]
[Caregivers]
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Information on patients will be collected from all female and male out-patients with a diagnosis of wAMD who currently receive anti-VEGF therapy with proactive regimen at Kozawa Eye Hospital (Mito-city, Japan). Of these, patients who are accompanied by his/her caregiver and the caregiver (a pair of patient-caregiver) who satisfy eligibility listed below will be recruited for the assessment of primary and secondary objectives.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Japan |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| D008268 | Macular Degeneration |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D013315 | Stress, Psychological |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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Anti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc. |
| At Baseline |
| Frequency of treatments | Number of a therapeutic agent given to patients | At baseline |
| Length of treatment | Duration of a therapeutic agent received | At baseline |
| Dosing schedule | The schedule of doses of a therapeutic agent per unit of time | At baseline |
| Percentage of patients accompanied by primary caregivers | At baseline |
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |