UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000432 |
|---|---|
| Receipt number | R000000523 |
| Scientific Title | A randomized controlled trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema. |
| Date of disclosure of the study information | 2006/06/21 |
| Last modified on | 2008/02/12 16:38:13 |
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Basic information
Public title
A randomized controlled trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Acronym
A trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Scientific Title
A randomized controlled trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Scientific Title:Acronym
A trial of triamcinolone intravitreal injection versus vitrectomy for diabetic macular edema.
Region
| Japan |
Condition
Condition
Patients with diabetic macula edema.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of treatment with diabetic macular edema.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Foveal thickness using optical coherent tomography
Key secondary outcomes
Best correlate visual acuity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
4 mg triamcinolone intravitreal injection
Interventions/Control_2
vitrectomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients with type 2 diabetes mellitus
(2)HbA1c less than 10%
(3)Foveal thickness more than 300 micron m on OCT3000
(4)Visual acuity of 0.3-1.0 logMAR
Key exclusion criteria
Exclusion criteria were: (1)active proliferatve diabetic retinopathy: (2) previous vitreoretinal surgery; (3) treatment of laser photocoagulation within 3 months; (4) other treatments for diabetic macular edema within 3months; (5) a history of glaucoma and ocular hypertention
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Faculty of medicine, Kagoshima university graduate school of medicine and dental sciences
Division name
Department of ophthalmology,
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5402
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihito Doi |
Organization
Faculty of medicine, Kagoshima university graduate school of medicine and dental sciences
Division name
Department of ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5402
Homepage URL
doi@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Faculty of medicine, Kagoshima university graduate school of medicine and dental sciences
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine, Kagoshima university graduate school of medicine and dental sciences
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 06 | Month | 21 | 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
Date of protocol fixation
| 2006 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 06 | Month | 20 | Day |
Last modified on
| 2008 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000523
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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