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


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


  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.