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

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

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.

Study Overview

• Status: Completed
• Conditions: Wet Macular Degeneration
• Intervention / Treatment: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Japan
  • Many Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRN group; wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN)	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Anti-VEGF therapy following the Summary of Product Characteristics
TAE group; wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE)	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Anti-VEGF therapy following the Summary of Product Characteristics
PRN-to-TAE switcher group; wAMD patients treated with anti-VEGF therapy and switching from PRN to TAE regimens	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Anti-VEGF therapy following the Summary of Product Characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At enrollment
Relationship between BIC-11 and the number of hospital visits for wAMD treatments		Up to 1 year
Frequency of hospital visits		Up to 1 year
Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)		Up to 1 year
Estimated costs spent by accompanying caregivers on hospital visits for wAMD management		Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Enrollment
Types of treatments for wAMD	Anti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc.	At Baseline
Frequency of treatments	Number of a therapeutic agent given to patients	At baseline
Length of treatment	Duration of a therapeutic agent received	At baseline
Dosing schedule	The schedule of doses of a therapeutic agent per unit of time	At baseline
Percentage of patients accompanied by primary caregivers		At baseline

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2015
• Primary Completion (Actual): March 30, 2016
• Study Completion (Actual): July 30, 2016

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Caregiver burden; Age-related macular degeneration; Anti-vascular endothelial growth factor (VEGF) therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Eye Diseases; Retinal Degeneration; Retinal Diseases; Stress, Psychological; Macular Degeneration; Wet Macular Degeneration; Caregiver Burden; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 17945