UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061304 |
|---|---|
| Receipt number | R000070145 |
| Scientific Title | Systemic SGLT2 Inhibition for Diabetic Macular Edema: A Scoping Review |
| Date of disclosure of the study information | 2026/04/18 |
| Last modified on | 2026/04/18 04:02:14 |
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Basic information
Public title
Systemic SGLT2 Inhibition for Diabetic Macular Edema: A Scoping Review
Acronym
Systemic SGLT2 Inhibition for Diabetic Macular Edema: A Scoping Review
Scientific Title
Systemic SGLT2 Inhibition for Diabetic Macular Edema: A Scoping Review
Scientific Title:Acronym
Systemic SGLT2 Inhibition for Diabetic Macular Edema: A Scoping Review
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
Diaetic Maclar Edema
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the usefulness of SGLT2 inhibitors in diabetic macular edema through a scoping review.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The usefulness of SGLT2 inhibitors for diabetic macular edema will be evaluated based on 1) prevention of the onset of diabetic macular edema, 2) prevention of the progression of diabetic retinopathy, and 3) reduction of the need for therapeutic intervention for diabetic macular edema.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Articles found on PubMed using the following search terms:
Diaetic Maclar Edema, Diaetic Maclar Oedema, Diabetic Retinopathy and SGLT2 inhibitor
Key exclusion criteria
Publications that do not mention diabetic macular edema
Publications concerning macular edema not caused by diabetic macular edema
Comments on the paper
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
292-0822
Address
1010 Sakurai, Kisarazu
TEL
0438-36-1071
bassyna6ce1484@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
292-0822
Address
1010 Sakurai, Kisarazu
TEL
0438-36-1071
Homepage URL
bassyna6ce1484@yahoo.co.jp
Sponsor or person
Institute
Kimitsu Chuo Hospital
Institute
Department
Personal name
Ryoichi Ishibashi
Funding Source
Organization
Kimitsu Chuo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kimitsu Chuo Hospital
Address
1010 Skurai. Kisarazu
Tel
0438-36-1071
bassyna6ce1484@yahoo.co.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
Please Select
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 18 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a scoping review and does not require ethics committee approval. It comprehensively analyzes and integrates related basic research, database studies, and intervention studies.
Management information
Registered date
| 2026 | Year | 04 | Month | 18 | Day |
Last modified on
| 2026 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070145
