UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008957 |
|---|---|
| Receipt number | R000010506 |
| Scientific Title | A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema. |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2015/12/01 17:45:10 |
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Basic information
Public title
A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.
Acronym
A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.
Scientific Title
A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.
Scientific Title:Acronym
A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.
Region
| Japan |
Condition
Condition
diffuse diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness at improving visual acuity and decreasing central macular thickness in early vitrectomy for diffuse diabetic macular edema with intravitreal injection of triamcinolone acetonide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
visual acuity
central macular thickness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Pars plana vitrectomy and follow up for 24 months.
Interventions/Control_2
Intravitreal injection of triamcinolone acetonide and follow up for 24 months.
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).
BCVA between 58 and 74 letters of a ETDRS visual acuity scale.
Key exclusion criteria
Eyes of signs of vitreomacular traction on biomicroscopy or OCT.
Eyes with active proliferative DR.
Eyes with known a history of glaucoma,optic nerve atrophy,vitrectomy,intravitreal injection,subtenon injection.
Eyes with known a history of photocoagulation within 3 months,cataract operation within 6 months.
Patients with any of serious heart disease, cerebrovascular disease,blood disorder, renal failure, malignant tumor, systemic steroids.
Patients with HbA1c 10% or higher, or systolic blood pressure of more than 180 mmHg or diastolic blood pressure more than 110 mmHg.
Patients with known as steroid responder.
Target sample size
162
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
Department of Ophthalmology
Zip code
Address
Sakuragaoka 8-35-1, Kagoshima, 890-8520 Japan
TEL
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Science
Division name
Department of Ophthalmology
Zip code
Address
Sakuragaoka 8-35-1, Kagoshima, 890-8520 Japan
TEL
099-275-5402
Homepage URL
tsakamot@m3.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
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 10 | 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
| 2012 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | 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
| 2012 | Year | 09 | Month | 21 | Day |
Last modified on
| 2015 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010506
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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