UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031089 |
|---|---|
| Receipt number | R000035507 |
| Scientific Title | A prospective multicenter study of the change of diabetis macular edema before and after the hemodialysis introduction and its related factor. |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2023/08/10 17:38:42 |
* 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
A prospective multicenter study of the change of diabetis macular edema before and after the hemodialysis introduction and its related factor.
Acronym
A prospective multicenter study of the change of diabetis macular edema before and after the hemodialysis introduction and its related factor.
Scientific Title
A prospective multicenter study of the change of diabetis macular edema before and after the hemodialysis introduction and its related factor.
Scientific Title:Acronym
A prospective multicenter study of the change of diabetis macular edema before and after the hemodialysis introduction and its related factor.
Region
| Japan |
Condition
Condition
Diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the effect of hemodialysis introduction for diabetic macular edema change prospectively, and to investigate the factor related to its change.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of central retinal thickness and best-corrected visual acuity before and after hemodialysis introduction (1, 3, 6, 9, and 12 months)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with diabetic retinopathy
2) Patients who could follow up more than six months after hemodialysis introduction
Key exclusion criteria
1) Patients who uses a drug causing macular edema
2) Patients who were judged to be inappropriate as a subject by investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Matsumura |
Organization
Faculty of Medical Science, University of Fukui
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaiduki, Matsuoka, Yoshida, Fukui
TEL
0776-61-8403
tmatsu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Matsumura |
Organization
Faculty of Medical Science, University of Fukui
Division name
Ophthalmology
Zip code
910-1193
Address
23-3 Shimoaiduki, Matsuoka, Yoshida, Fukui
TEL
0776-61-8403
Homepage URL
tmatsu@u-fukui.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medical Science, University of Fukui
Institute
Department
Personal name
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
Medical research support center, University of Fukui
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel
0776-61-8529
chiken@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
福井大学医学部附属病院（福井県）、東京医科大学八王子医療センター（東京都）、奈良県立医科大学（奈良県）、兵庫医科大学（兵庫県）、東京女子医科大学糖尿病センター（東京都）、防衛医科大学校病院（埼玉県）、信州大学（長野県）、聖路加国際病院（東京都）、三重大学（三重県）、山口大学医学部（山口県）、市立札幌病院（北海道）、徳島大学（徳島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035507
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035507
Number of participants that the trial has enrolled
2
Results
It was suggested that diabetic macular edema improves with the introduction of hemodialysis.
Results date posted
| 2023 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with diabetes mellitus who were introduced to hemodialysis.
Participant flow
Patients who met the inclusion criteria were included.
Adverse events
No adverse events.
Outcome measures
Central retinal thickness decreased after the introduction of hemodialysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(The subjects) Patients who had diabetic retinopathy and became the hemodialysis introduction between December 1, 2017 and December 31, 2021.
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035507
