UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049916 |
|---|---|
| Receipt number | R000056851 |
| Scientific Title | Efficacy and safety of intravitreal faricimab in Japanese patients with diabetic macular edema |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/05/02 12:44:28 |
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Basic information
Public title
Efficacy and safety of intravitreal faricimab in Japanese patients with diabetic macular edema
Acronym
Intravitreal injection of faricimab on diabetic macular edema
Scientific Title
Efficacy and safety of intravitreal faricimab in Japanese patients with diabetic macular edema
Scientific Title:Acronym
Intravitreal injection of faricimab on diabetic maculopathy
Region
| Japan |
Condition
Condition
Diabetic maculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the improvement of best corrected visual acuity and central macular thickness with intravit of best corrected visual acuity and central macular thickness with intravitreal
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
best corrected visual acuity
Key secondary outcomes
central macular thickness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravitreal injection of faricimab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diabetic macular edema who are outpatients in the department of Ophthalmology, Seirei Hamamatsu General Hospital and judged to be suitable for faricimab treatment.
Patients signed in written informed consent form
Key exclusion criteria
Patients who have received the other treatment for diabetic macular edema
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Ophthalmology
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka
TEL
0534742222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Ophthalmology
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka, Japan
TEL
0534742222
Homepage URL
obana@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Akira Obana
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka
Tel
0534742222
m-kimata@sis.seirei.or.jp
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
聖隷浜松病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | 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 | 12 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056851
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
