UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055623 |
|---|---|
| Receipt number | R000063565 |
| Scientific Title | Effect of Drug Switch on Diabetic Macular Edema |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2024/09/26 00:24:28 |
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Basic information
Public title
Multicenter Registry Study on the Effectiveness of Drug Switch for Diabetic Macular Edema
Acronym
Effect of Drug Switch on Diabetic Macular Edema
Scientific Title
Effect of Drug Switch on Diabetic Macular Edema
Scientific Title:Acronym
Effect of Drug Switch on Diabetic Macular Edema
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a registry of diabetic macular edema (DME) patients treated with anti-vascular endothelial growth factor (VEG)F drug switch therapy in clinical practice and determine the effect of switch therapy on DME.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indications for Anti-VEGF Drug Switch for DME and Changes in Visual Function and Imaging Findings
Key secondary outcomes
Correlation analysis between surgical procedures and findings and the course of visual function after treatment
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
Patients on anti-VEGF therapy for DME who switched to another anti-VEGF agent (currently there are a total of six approved anti-VEGF agents: Lucentis Airea, ranibizumab-BS, Babiesumo Beobuy Airea 8 mg).
Key exclusion criteria
Cases in which the patient has expressed his/her refusal to be registered
Cases in which the patient withdraws consent
Patients who need to give their consent
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Faculty of Medicine, Yamagata University.
Division name
Department of Ophthalmology and Visual Science,
Zip code
990-9585
Address
2-2-2, Iida-nishi, Yamagata, Japan.
TEL
023-628-5374
sugmochi92@gmail.com
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Faculty of Medicine, Yamagata University.
Division name
Department of Ophthalmology and Visual Science,
Zip code
990-9585
Address
2-2-2, Iida-nishi, Yamagata, Japan.
TEL
023-628-5374
Homepage URL
sugmochi92@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Yamagata University.
Institute
Department
Personal name
Masahiko Sugimoto
Funding Source
Organization
Own
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
Faculty of Medicine, Yamagata University.
Address
2-2-2, Iida-nishi, Yamagata, Japan.
Tel
023-628-5374
sugmochi92@gmail.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
| 2024 | Year | 09 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063565
