UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017250 |
|---|---|
| Receipt number | R000018865 |
| Scientific Title | Vitrectomy combined with intravitreal triamcinolone acetonide injection for diabetic macular edema |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2019/03/11 13:28:29 |
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Basic information
Public title
Vitrectomy combined with intravitreal triamcinolone acetonide injection for diabetic macular edema
Acronym
Vitrectomy combined with IVTA for DME
Scientific Title
Vitrectomy combined with intravitreal triamcinolone acetonide injection for diabetic macular edema
Scientific Title:Acronym
Vitrectomy combined with IVTA 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 efficacy of vitrectomy combined with intravitreal injection of triamcinolone acetonide for the treatment of nontractional diabetic macular edema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Central retinal thickness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Intra-Vitreal Triamcinolone Acetonide
Interventions/Control_2
Vitrectormy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes
Diabetic macular edema
Foveal thickness more than 300 micrometers
Intraocular pressure less than 21 mmHg
Diagnosed as needed vitrectomy
Key exclusion criteria
History of previous vitrectomy.
Previous history of treatment with agents including triamcninolone acetonide, anti-VEGF therapy, immunosuppressant drugs and artificial dialysis within 24 weeks.
Modification of insulin treatments within 12 weeks.
Previous history of laser treatments or intraocular surgery within 12 weeks.
Previous history of systemic drugs such as steroid, carbonate dehydratase inhibitor and warfarin within 4 weeks.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kunikata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7294
Homepage URL
kunikata@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Wakamoto Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018865
| 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 |
