UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012154 |
|---|---|
| Receipt number | R000014205 |
| Scientific Title | Choroidal structure of diabetic retinopathy eye on OCT image after the treatment |
| Date of disclosure of the study information | 2013/10/29 |
| Last modified on | 2013/10/29 08:46:00 |
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Basic information
Public title
Choroidal structure of diabetic retinopathy eye on OCT image after the treatment
Acronym
Choroidal structure of DR on OCT
Scientific Title
Choroidal structure of diabetic retinopathy eye on OCT image after the treatment
Scientific Title:Acronym
Choroidal structure of DR on OCT
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the effect of intravitreal steroid and intravitreal anti-VEGF on diabetic retiopathy and/or choroidpathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
retinochodoiral strucure on OCT
Key secondary outcomes
Frequency of recurrence
Complications
visual acutiy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravitreal injection of triamcinolone acetonide
Interventions/Control_2
Intravitreal injection of anti-VEGF drug and follow up
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
Aged 18 years or older.
Diffuse DME(CMT 300microns < determined by OCT).
Visual acuity: 1.0 logMAR >
Key exclusion criteria
Eyes with active proliferative DR.
Eyes with known a history of glaucoma,optic nerve atrophy.
History of laser photocoagulation within 3 months
History of intravitreal injection or subrenon injection for diabetic macular edema within 3months.
Aphakia
Patients with any of serious heart disease, cerebrovascular disease,blood disorder, renal failure, malignant tumor, systemic steroids.
Cases clear OCT images can not be obtained
Patients with known as steroid responder
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Science
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
99-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shozo Sonoda |
Organization
Kagoshima University Graduate School of Medical and Dental Science
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
99-275-5402
Homepage URL
shou@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Science
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate School of Medical and Dental Science
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
Address
Tel
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
| 2013 | Year | 10 | Month | 29 | 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
| 2013 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 29 | Day |
Last modified on
| 2013 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014205
| 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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