UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044771 |
|---|---|
| Receipt number | R000051061 |
| Scientific Title | Change in aqueous cytokine level after intravitreal anti-VEGF therapy in diabetic macular edema |
| Date of disclosure of the study information | 2021/07/06 |
| Last modified on | 2021/07/06 16:09:02 |
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Basic information
Public title
Change in aqueous cytokine level after intravitreal anti-VEGF therapy in diabetic macular edema
Acronym
the effect of anti-VEGF therapy on aqueous cytokine level in DME
Scientific Title
Change in aqueous cytokine level after intravitreal anti-VEGF therapy in diabetic macular edema
Scientific Title:Acronym
the effect of anti-VEGF therapy on aqueous cytokine level in DME
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effect of anti-VEGF therapy on aqueous cytokine level.
Basic objectives2
Others
Basic objectives -Others
the relationship between the change of cytokine level and therapeutic effect
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change in aqueous cytokine level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
aqueous humor collection
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
DME patients who receive anti VEGF agent.
Key exclusion criteria
treatment history (surgery or photocoagulation) in 3 months.
allergy
pregnant
participating any other study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | masakazu |
| Middle name | |
| Last name | morioka |
Organization
Fukui University
Division name
ophthalmology
Zip code
9101193
Address
shimoaizuki, matsuoka, eiheijicho, Fukui
TEL
0776613111
mmorioka@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | masakazu |
| Middle name | |
| Last name | morioka |
Organization
Fukui University
Division name
Ophthalmology
Zip code
9101193
Address
shimoaizuki, matsuoka, eiheijicho, Fukui
TEL
0776613111
Homepage URL
mmorioka@u-fukui.ac.jp
Sponsor or person
Institute
Fukui University
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
Fukui University IRB
Address
shimoaizuki, matsuoka, eiheijicho, Fukui
Tel
0776613111
mmorioka@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
| 2021 | Year | 07 | 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
| 2021 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051061
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
