Wet Macular DegenerationNCT02541084
Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) in Japan
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- 18 Aug 2015to 30 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- [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
Who cannot join
- [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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Wet Macular Degeneration
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Age-related macular degeneration, Caregiver burden, Anti-vascular endothelial growth factor (VEGF) therapy
- Medical subject headings
- Wet Macular Degeneration, Macular Degeneration, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Drug
Anti-VEGF therapy following the Summary of Product Characteristics
| Study group | Role | What they receive |
|---|---|---|
| PRN group | wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN) Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | |
| TAE group | wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE) Receives: 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 Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Relationship between BIC-11 and the number of hospital visits for wAMD treatments
Measured: Up to 1 year
Frequency of hospital visits
Measured: Up to 1 year
Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)
Measured: Up to 1 year
Estimated costs spent by accompanying caregivers on hospital visits for wAMD management
Measured: Up to 1 year
Secondary outcomes (6)
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.
Measured: At Enrollment
Types of treatments for wAMD
Anti-VEGF(anti vascular endothelial growth factor)drugs, laser therapy, Photodynamic Therapy,etc.
Measured: At Baseline
Frequency of treatments
Number of a therapeutic agent given to patients
Measured: At baseline
Length of treatment
Duration of a therapeutic agent received
Measured: At baseline
Dosing schedule
The schedule of doses of a therapeutic agent per unit of time
Measured: At baseline
Percentage of patients accompanied by primary caregivers
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start18 Aug 2015
- Primary completion30 Mar 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541084
- Sponsor's protocol ID
- 17945
- Status last verified
- Aug 2017
- First submitted
- 5 Aug 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) Treatment in Real-life Japanese Settings.
- ClinicalTrials.gov ID
- NCT02541084
- Acronym / sponsor ID
- 17945
- Conditions
- Wet Macular Degeneration
- Keywords
- Age-related macular degeneration, Caregiver burden, Anti-vascular endothelial growth factor (VEGF) therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRN group | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)wAMD-patients treated with anti-VEGF therapy ´pro re nata´ (PRN) |
| TAE group | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)wAMD-patients treated with anti-VEGF therapy ´treat-and-extend´ (TAE) |
| PRN-to-TAE switcher group | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)wAMD patients treated with anti-VEGF therapy and switching from PRN to TAE regimens |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- [Patients]
- [Caregivers]
Key exclusion criteria (6 listed)
- [Patients]
- [Caregivers]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Anti-VEGF therapy following the Summary of Product Characteristics | Drug | PRN group, PRN-to-TAE switcher group, TAE group |
Primary outcome
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.
Relationship between BIC-11 and the number of hospital visits for wAMD treatments
Time frame: Up to 1 year
Frequency of hospital visits
Time frame: Up to 1 year
Time spent by accompanying caregivers for a clinic visit for wAMD management (minutes)
Time frame: Up to 1 year
Estimated costs spent by accompanying caregivers on hospital visits for wAMD management
Time frame: Up to 1 year
6 secondary outcomes
Level of depression among caregivers (CES-D)
Time frame: At Enrollment
Types of treatments for wAMD
Time frame: At Baseline
Frequency of treatments
Time frame: At baseline
Length of treatment
Time frame: At baseline
Dosing schedule
Time frame: At baseline
Percentage of patients accompanied by primary caregivers
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of caregiving burden on caregivers (BIC-11) (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.