UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030301 |
|---|---|
| Receipt number | R000034604 |
| Scientific Title | Clinical study in relation between effect of anti-VEGF agents and cytokines for diabetic macular edema |
| Date of disclosure of the study information | 2017/12/08 |
| Last modified on | 2023/12/13 09:15:01 |
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Basic information
Public title
Clinical study in relation between effect of anti-VEGF agents and cytokines for diabetic macular edema
Acronym
Relationship between effect of anti-VEGF agents and cytokines for DME
Scientific Title
Clinical study in relation between effect of anti-VEGF agents and cytokines for diabetic macular edema
Scientific Title:Acronym
Relationship between effect of anti-VEGF agents and cytokines for 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 agents for diabetic macular edema.
Basic objectives2
Others
Basic objectives -Others
To evaluate the relation between the effect of anti-VEGF agents and cytokines for diabetic macular edema.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity and central macular thickness every month
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
injection of anti-VEGF agents 0.05 ml (first time and at the recurrence)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)visual acuity <0.7
2)central macular thickness > 300
Key exclusion criteria
1)patients who were performed operation
2)patients with active uveitis
3)patients with rubeosis
4)patients with uncontrolled glaucoma
5)patients with severe diabetic retinopathy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Shimura |
Organization
Hachioji Medical Center, Tokyo Medical University
Division name
Department of Ophthalmology
Zip code
193-0998
Address
1163, Tatemachi, Hachioji, Tokyo 193-0998
TEL
042-665-5611
masahiko@v101.vaio.ne.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Noma |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Ophthalmology
Zip code
193-0998
Address
1163, Tatemachi, Hachioji, Tokyo 193-0998
TEL
042-665-5611
Homepage URL
noma-hide@umin.ac.jp
Sponsor or person
Institute
Tokyo medical university
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Hachioji Medical Center
Address
1163, Tatemachi, Hachioji, Tokyo 193-0998
Tel
0426655611
masahiko@v101.vaio.ne.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
| 2017 | Year | 12 | Month | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | 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
| 2017 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034604
