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

NCT02541084 | Completed

• 1 other identifier: 17945
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Wet Macular Degeneration

Keywords

Age-related macular degeneration; Caregiver burden; Anti-vascular endothelial growth factor (VEGF) therapy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Level of depression among caregivers (CES-D)

  At Enrollment

• Types of treatments for wAMD

  At Baseline

• Frequency of treatments

  At baseline

• Length of treatment

  At baseline

• Dosing schedule

  At baseline

Study Arms (3)

PRN group

wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN)

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

TAE group

wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE)

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

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)

Interventions

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

Anti-VEGF therapy following the Summary of Product Characteristics

PRN group; PRN-to-TAE switcher group; TAE group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \[Patients\]
• 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

You may not qualify if:

• \[Patients\]
• 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

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Conditions

Wet Macular Degeneration; Macular Degeneration; Caregiver Burden

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: September 4, 2015
• Study Start: August 18, 2015
• Primary Completion: March 30, 2016
• Study Completion: July 30, 2016
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

JP (1)