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

Overview

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.

Full Title of Study: “Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) Treatment in Real-life Japanese Settings.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 30, 2016

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Degree of caregiving burden on caregivers (BIC-11)
    • Time Frame: 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.
  • Relationship between BIC-11 and the number of hospital visits for wAMD treatments
    • Time Frame: Up to 1 year
  • Frequency of hospital visits
    • Time Frame: Up to 1 year
  • Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)
    • Time Frame: Up to 1 year
  • Estimated costs spent by accompanying caregivers on hospital visits for wAMD management
    • Time Frame: Up to 1 year

Secondary Measures

  • Level of depression among caregivers (CES-D)
    • Time Frame: 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
    • Time Frame: At Baseline
    • Anti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc.
  • Frequency of treatments
    • Time Frame: At baseline
    • Number of a therapeutic agent given to patients
  • Length of treatment
    • Time Frame: At baseline
    • Duration of a therapeutic agent received
  • Dosing schedule
    • Time Frame: At baseline
    • The schedule of doses of a therapeutic agent per unit of time
  • Percentage of patients accompanied by primary caregivers
    • Time Frame: At baseline

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Collaborator
    • Regeneron Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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