Clinical trial NCT02541084: Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) in Japan
Official title: Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) Treatment in Real-life Japanese Settings.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Macular Degeneration
Keywords: Age-related macular degeneration
Caregiver burden
Anti-vascular endothelial growth factor (VEGF) therapy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2015-09-04
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Information on patients will be collected from all female and male out-patients with a diagnosis of wAMD who currently receive anti-VEGF therapy with proactive regimen at Kozawa Eye Hospital (Mito-city, Japan). Of these, patients who are accompanied by his/her caregiver and the caregiver (a pair of patient-caregiver) who satisfy eligibility listed below will be recruited for the assessment of primary and secondary objectives.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Degree of caregiving burden on caregivers (BIC-11)
timeFrame: At enrollment
measure: Relationship between BIC-11 and the number of hospital visits for wAMD treatments
timeFrame: Up to 1 year
measure: Frequency of hospital visits
timeFrame: Up to 1 year
measure: Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)
timeFrame: Up to 1 year
measure: Estimated costs spent by accompanying caregivers on hospital visits for wAMD management
timeFrame: Up to 1 year
Secondary outcomes:
measure: Level of depression among caregivers (CES-D)
timeFrame: At Enrollment
measure: Types of treatments for wAMD
timeFrame: At Baseline
measure: Frequency of treatments
timeFrame: At baseline
measure: Length of treatment
timeFrame: At baseline
measure: Dosing schedule
timeFrame: At baseline
measure: Percentage of patients accompanied by primary caregivers
timeFrame: At baseline
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: