Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) in Japan

Study Overview
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Brief Summary
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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.

Official Title
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Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) Treatment in Real-life Japanese Settings.

Conditions
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Wet Macular Degeneration

Intervention / Treatment
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* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PRN group<br>wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN) | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Anti-VEGF therapy following the Summary of Product Characteristics<br>|
| TAE group<br>wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE) | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Anti-VEGF therapy following the Summary of Product Characteristics<br>|
| PRN-to-TAE switcher group<br>wAMD patients treated with anti-VEGF therapy and switching from PRN to TAE regimens | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Anti-VEGF therapy following the Summary of Product Characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration, Caregiver burden, Anti-vascular endothelial growth factor (VEGF) therapy