UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047686 |
|---|---|
| Receipt number | R000054370 |
| Scientific Title | VABYSMO solution for intravitreal injection 120mg/mL, General drug use-results survey - Subfoveal choroidal neovascularization secondary to age-related macular degeneration, Diabetic macular edema - |
| Date of disclosure of the study information | 2022/05/25 |
| Last modified on | 2022/12/28 07:00:25 |
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Basic information
Public title
VABYSMO solution for intravitreal injection 120mg/mL, General drug use-results survey - Subfoveal choroidal neovascularization secondary to age-related macular degeneration, Diabetic macular edema -
Acronym
VABYSMO solution for intravitreal injection 120mg/mL, General drug use-results survey - Subfoveal choroidal neovascularization secondary to age-related macular degeneration, Diabetic macular edema -
Scientific Title
VABYSMO solution for intravitreal injection 120mg/mL, General drug use-results survey - Subfoveal choroidal neovascularization secondary to age-related macular degeneration, Diabetic macular edema -
Scientific Title:Acronym
VABYSMO solution for intravitreal injection 120mg/mL, General drug use-results survey - Subfoveal choroidal neovascularization secondary to age-related macular degeneration, Diabetic macular edema -
Region
| Japan |
Condition
Condition
Subfoveal choroidal neovascularization secondary to age-related macular degeneration (nAMD), Diabetic macular edema (DME)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To calculate the incidence of endophthalmitis when VABYSMO is used for subfoveal choroidal neovascularization secondary to age-related macular degeneration or diabetic macular edema, under conditions of actual clinical use, in order to consider where there is at the greater risk for developing endophthalmitis than clinical trial results extremely.
Safety specifications: Infectious endophthalmitis, endophthalmitis, rhegmatogenous retinal detachment and retinal detachment, retinal pigment epithelium detachment (nAMD), intraocular pressure elevation, arterial thromboembolism event.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main survey items etc.
1)Information on facilities:
Name of facility, name of department, name of physician who fills out the case report form.
2)Patient demographics:
Patient initials, sex, pregnancy status, age at administration start, medical category (outpatient / inpatient), identification number, reason for use, height, weight, blood pressure (systolic / diastolic), smoking, disease duration, allergic history, previous medical history, complications.
(The below, only nAMD)
Exudative nAMD type.
(The below, only DME)
Classification of diabetes mellitus, disease duration of diabetes mellitus, HbA1c of the start of administration, diabetic macular edema type, the type of diabetic retinopathy.
3)Prior treatment history:
Name of prior treatment, treatment area, reason for discontinuation.
4)Administration status of VABYSMO:
Amount in a single dose, administration eye, administration date, status of VABYSMO at the end of the observation period.
5)Concomitant drugs:
Name of drug, treatment area, the start date of administration, the terminated date of administration.
6)Combination therapy:
Name of therapy, treatment area, treatment date.
7)If adverse events occur:
Name of adverse event or laboratory test values abnormality, date of onset, onset area, severity, treatment (VABYSMO, other), outcome, date of outcome, causal relationship (VABYSMO, other cause).
8)Visual acuity:
Decimal visual acuity (only VABYSMO administration eye), (at the start of administration, at 16 weeks after the start of administration, at 64 weeks after the start of administration, at the terminated date of administration).
9)Central subfield thickness:
Central subfield thickness (only VABYSMO administration eye), (at the start of administration, at 16 weeks after the start of administration, at 64 weeks after the start of administration, at the terminated date of administration).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Target cases for enrollment: Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration or diabetic macular edema to whom VABYSMO is scheduled to be administered for the first time during the enrollment period in facilities where a contract for this surveillance has been concluded.
Target cases for case report form collection: All patients from among the target cases for enrollment who use VABYSMO.
Key exclusion criteria
None
Target sample size
1660
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Nomura |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
nomuramkt@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ryousuke |
| Middle name | |
| Last name | Harada |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety Science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
haradarus@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054370
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
