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

Bayer

Status: Completed

Conditions: Wet Macular Degeneration

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02541084

17945

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 3 patient groups

PRN group

Description:

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

Treatment:

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

TAE group

Description:

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

Treatment:

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

PRN-to-TAE switcher group

Description:

wAMD patients treated with anti-VEGF therapy and switching from PRN to TAE regimens

Treatment:

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