UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020376 |
|---|---|
| Receipt number | R000023531 |
| Scientific Title | Effect of intravitreal triamcinolone injection combined with vitrectomy for proliferative diabetic retinopathy. |
| Date of disclosure of the study information | 2015/12/28 |
| Last modified on | 2018/02/05 14:41:13 |
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Basic information
Public title
Effect of intravitreal triamcinolone injection combined with vitrectomy for proliferative diabetic retinopathy.
Acronym
Effect of intravitreal triamcinolone injection combined with vitrectomy for proliferative diabetic retinopathy.
Scientific Title
Effect of intravitreal triamcinolone injection combined with vitrectomy for proliferative diabetic retinopathy.
Scientific Title:Acronym
Effect of intravitreal triamcinolone injection combined with vitrectomy for proliferative diabetic retinopathy.
Region
| Japan |
Condition
Condition
Diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether intravitreal triamcinolone injection combined with vitrectomy prevent postoperative inflammation and macular edema worsening.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Central retinal thickness (3 days, 1 week, and 1, 3, 6, 12 months after vitrectomy)
Key secondary outcomes
Postoperative visual acuity, flare value in anterior chamber, intraocular pressure, and number of intraoperative photocoagulation(3 days, 1 week, and 1, 3, 6, 12 months after vitrectomy)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Triamcinolone acetonide, 4mg, intravitreal injection
Interventions/Control_2
Control group
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
1) Patients with the document agreement
2) Patients with diabetes mellitus
3) Patients with proliferative diabetic retinopathy who were scheduled vitrectomy
Key exclusion criteria
1) Patients who received intravitreal triamcinolone injection within three months
2) Patients receiving systemic therapy of steroid drugs
3) Patients who was judged to be inappropriate as a subject by doctor in charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiro Matsumura |
Organization
Faculty of Medical Science, University of Fukui
Division name
Ophthalmology
Zip code
Address
23-3 Shimoaiduki, Matsuoka, Yoshida, Fukui
TEL
0776-61-8403
tmatsu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Matsumura |
Organization
Faculty of Medical Science, University of Fukui
Division name
Ophthalmology
Zip code
Address
23-3 Shimoaiduki, Matsuoka, Yoshida, Fukui
TEL
0776-61-8403
Homepage URL
tmatsu@u-fukui.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Medical Science, University of Fukui
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
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
福井大学医学部附属病院（福井県）、信州大学医学部附属病院（長野県）、三重大学医学部附属病院（三重県）、東京医科大学八王子医療センター（東京都）、徳島大学病院（徳島県）、東京女子医科大学糖尿病センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023531
