Trial Condition(s):
Wet Macular Degeneration
Caregiver burden of wet age-related macular degeneration (wAMD) in Japan
Bayer Identifier:
17945
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Caregiver burden of wet age-related macular degeneration (wAMD) treatment in real-life Japanese settings.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- 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.Timeframe: At enrollment
- Relationship between BIC-11 and the number of hospital visits for wAMD treatmentsTimeframe: Up to 1 year
- Frequency of hospital visitsTimeframe: Up to 1 year
- Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)Timeframe: Up to 1 year
- Estimated costs spent by accompanying caregivers on hospital visits for wAMD managementTimeframe: Up to 1 year
Secondary Outcome
- 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.Timeframe: At Enrollment
- Types of treatments for wAMDAnti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc.Timeframe: At Baseline
- Frequency of treatmentsNumber of a therapeutic agent given to patientsTimeframe: At baseline
- Length of treatmentDuration of a therapeutic agent receivedTimeframe: At baseline
- Dosing scheduleThe schedule of doses of a therapeutic agent per unit of timeTimeframe: At baseline
- Percentage of patients accompanied by primary caregiversTimeframe: At baseline
Additional Information
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