check_circleStudy Completed

Wet Macular Degeneration

Bayer Identifier:

17945

ClinicalTrials.gov Identifier:

NCT02541084

EudraCT Number:

Not Available

EU CT Number:

Not Available
Caregiver burden of wet age-related macular degeneration (wAMD) in Japan

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A

  • - [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
  • - [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
72
Trial Dates
August 2015 - July 2016
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

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.
    date_rangeTime Frame:
    At enrollment
    enhanced_encryption
    Safety Issue:
    No
  • Relationship between BIC-11 and the number of hospital visits for wAMD treatments
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Frequency of hospital visits
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Estimated costs spent by accompanying caregivers on hospital visits for wAMD management
    date_rangeTime Frame:
    Up to 1 year
    enhanced_encryption
    Safety Issue:
    No

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.
    date_rangeTime Frame:
    At Enrollment
    enhanced_encryption
    Safety Issue:
    No
  • Types of treatments for wAMD
    Anti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc.
    date_rangeTime Frame:
    At Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Frequency of treatments
    Number of a therapeutic agent given to patients
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Length of treatment
    Duration of a therapeutic agent received
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Dosing schedule
    The schedule of doses of a therapeutic agent per unit of time
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of patients accompanied by primary caregivers
    date_rangeTime Frame:
    At baseline

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
N/A

Additional Information

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