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Completed

NCT Number: NCT02541084

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.

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Key information

Conditions

Wet Macular Degeneration Behavior Behavioral Symptoms Caregiver Burden Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Stress, Psychological

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Drug

Anti-VEGF therapy following the Summary of Product Characteristics

Primary outcomes

  1. 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.

  2. Relationship between BIC-11 and the number of hospital visits for wAMD treatments

    Time frame: Up to 1 year

  3. Frequency of hospital visits

    Time frame: Up to 1 year

  4. Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)

    Time frame: Up to 1 year

  5. Estimated costs spent by accompanying caregivers on hospital visits for wAMD management

    Time frame: Up to 1 year

Secondary outcomes

  1. 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.

  2. Types of treatments for wAMD

    Time frame: At Baseline

    Anti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc.

  3. Frequency of treatments

    Time frame: At baseline

    Number of a therapeutic agent given to patients

  4. Length of treatment

    Time frame: At baseline

    Duration of a therapeutic agent received

  5. Dosing schedule

    Time frame: At baseline

    The schedule of doses of a therapeutic agent per unit of time

  6. Percentage of patients accompanied by primary caregivers

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2015
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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