UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056634 |
|---|---|
| Receipt number | R000064730 |
| Scientific Title | Effects of SGLT2 Inhibitors on Diabetic Macular Edema |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/07/07 09:47:46 |
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Basic information
Public title
Effects of SGLT2 Inhibitors on Diabetic Macular Edema
Acronym
Effects of SGLT2 Inhibitors on Diabetic Macular Edema
Scientific Title
Effects of SGLT2 Inhibitors on Diabetic Macular Edema
Scientific Title:Acronym
Effects of SGLT2 Inhibitors on Diabetic Macular Edema
Region
| Japan |
Condition
Condition
Diabetic Macular Edema
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By observing the pathological changes in diabetic macular edema before and after taking SGLT2 inhibitors, we will test whether SGLT2 inhibitors are effective in improving diabetic macular edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corrected visual acuity (logMAR conversion) and central retinal thickness by retinal optical coherence tomography in both eyes before and 4, 8, 12, 24, and 48 weeks after the start of SGLT2 inhibitor treatment.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients with no change in diabetes treatment for 4 weeks prior to screening test
Key exclusion criteria
Patients with iris neovascularization, vitreous hemorrhage, tractional retinal detachment, and active uveitis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Oshima |
Organization
Fukui University
Division name
Ophthalmology
Zip code
9101193
Address
23-3 Matsuoka-Shimogetsu, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL
0776-61-8403
osm@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Oshima |
Organization
Fukui University
Division name
Ophthalmology
Zip code
9101193
Address
23-3 Matsuoka-Shimogetsu, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
TEL
0776-61-8403
Homepage URL
osm@u-fukui.ac.jp
Sponsor or person
Institute
Fukui University
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3 Matsuoka-Shimogetsu, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
Tel
0776-61-8614
rinrisys@ml.u-fukui.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 06 | 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
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064730
