UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048888 |
|---|---|
| Receipt number | R000055688 |
| Scientific Title | Survey of treatment pattern and prognosis about diabetic macular edema in Japan |
| Date of disclosure of the study information | 2022/09/20 |
| Last modified on | 2022/09/08 16:00:27 |
* 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
Survey of treatment for diabetic macular edema in Japan
Acronym
STREAT-DME 2 study
Scientific Title
Survey of treatment pattern and prognosis about diabetic macular edema in Japan
Scientific Title:Acronym
STREAT-DME 2 study
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a nationwide survey on the treatment pattern and treatment prognosis for two years from the start of intervention for diabetic macular edema in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dynamic change of visual improvement after 2-years from initial intervention
Key secondary outcomes
Dynamic change of treatment pattern during 2 years of clinical course
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
treatment-naive diabetic macular edema who have medical record during 2 years since initial intervention
Key exclusion criteria
patients who had vitreous retinal disease other than diabetic retinopathy
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | SHIMURA |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Ophthalmology
Zip code
193-8639
Address
1163 Tate-machi, Hachioji, Tokyo
TEL
+81426655611
masahiko@v101.vaio.ne.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | SHIMURA |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Ophthalmology
Zip code
193-8639
Address
1163 Tate-machi, Hachioji, Tokyo
TEL
+81426655611
Homepage URL
kelloggmi@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board in Tokyo Medical University
Address
6-7-1 Nishi-Shinjuku, Shinjuku, Tokyo
Tel
0333426111
tokyo-med@esct.bvits.com
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 | 09 | Month | 20 | 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 | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Treatment naive diabetic macular edema
Initial intervention received from 2015 to 2019
Each case had medical record more than 2years since initial intervention
Visual acuity and central macular thickness recorded at the time of intervention and final date of 2-years.
Management information
Registered date
| 2022 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055688
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
