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

Wet Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541084
• Other study ID #: 17945
• Status: Completed
• Phase: N/A
• First received: August 5, 2015
• Last updated: August 21, 2017
• Start date: August 18, 2015
• Est. completion date: July 30, 2016

Study information

• Verified date: August 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 30, 2016
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF therapy following the Summary of Product Characteristics

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Relationship between BIC-11 and the number of hospital visits for wAMD treatments		Up to 1 year
Primary	Frequency of hospital visits		Up to 1 year
Primary	Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)		Up to 1 year
Primary	Estimated costs spent by accompanying caregivers on hospital visits for wAMD management		Up to 1 year
Secondary	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
Secondary	Types of treatments for wAMD	Anti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc.	At Baseline
Secondary	Frequency of treatments	Number of a therapeutic agent given to patients	At baseline
Secondary	Length of treatment	Duration of a therapeutic agent received	At baseline
Secondary	Dosing schedule	The schedule of doses of a therapeutic agent per unit of time	At baseline
Secondary	Percentage of patients accompanied by primary caregivers		At baseline

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