UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042242 |
|---|---|
| Receipt number | R000048231 |
| Scientific Title | Fact-finding survey of diabetic macular edema using big data and in clinical practice and examination of the usefulness of SGLT2 inhibitors |
| Date of disclosure of the study information | 2020/10/27 |
| Last modified on | 2023/06/07 13:29:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Fact-finding survey of diabetic macular edema using big data and in clinical practice and examination of the usefulness of SGLT2 inhibitors
Acronym
Fact-finding survey of diabetic macular edema using big data and in clinical practice and examination of the usefulness of SGLT2 inhibitors
Scientific Title
Fact-finding survey of diabetic macular edema using big data and in clinical practice and examination of the usefulness of SGLT2 inhibitors
Scientific Title:Acronym
Fact-finding survey of diabetic macular edema using big data and in clinical practice and examination of the usefulness of SGLT2 inhibitors
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the treatment of diabetic macular edema in the actual situation using big data, and to examine the safety and efficacy of SGLT2 inhibitors in patients with diabetic macular edema.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of anti-VEGF injections per year in patients with diabetic macular edema with and without SGLT2 inhibitors.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients being treated for diabetic macular edema
Key exclusion criteria
Patients with less than 6 months of hospital visits
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Koutaro |
| Middle name | |
| Last name | Yokote |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Endocrinology, Hematology and Gerontology,
Zip code
260-0856
Address
1-8-1 inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
+81-43-226-2092
kyokote@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
+81-438-36-1071
Homepage URL
ishibashi-cib@umin.net
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
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
Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu-city, Chiba, Japan
Tel
+81-438-36-1071
soumu@kc-hosp.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
684
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
This research is a database research using big data.
Management information
Registered date
| 2020 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048231
