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

Completed

• Conditions: Wet Macular Degeneration
• Interventions: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT02541084
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-05
• Study Start: 2015-08-18
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Primary Completion: 2016-03-30
• Study Completion: 2016-07-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PRN group	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN)
TAE group	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE)
PRN-to-TAE switcher group	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	wAMD patients treated with anti-VEGF therapy and switching from PRN to TAE regimens

Primary Outcome Measures

Name	Time	Method
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.
Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)	Up to 1 year
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
Estimated costs spent by accompanying caregivers on hospital visits for wAMD management	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
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.
Percentage of patients accompanied by primary caregivers	At baseline
Frequency of treatments	At baseline	Number of a therapeutic agent given to patients
Length of treatment	At baseline	Duration of a therapeutic agent received
Dosing schedule	At baseline	The schedule of doses of a therapeutic agent per unit of time