UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000455 |
|---|---|
| Receipt number | R000000553 |
| Scientific Title | A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation |
| Date of disclosure of the study information | 2006/07/27 |
| Last modified on | 2009/01/27 15:21:10 |
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Basic information
Public title
A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Acronym
A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Scientific Title
A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Scientific Title:Acronym
A randomized controlled trial on therapeutic effects of sub-Tenon's capsule injection of triamcinolone acetonide in prevention of occurrence and inhibition of progression of diabetic macular edema caused by panretinal photocoagulation
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this trial is to evaluate the safety and efficacy of sub-Tenon's capsule injection of triamcinolone acetonide in the prevention of occurrence and the inhibition of progression of diabetic macular edema caused by panretinal photocoagulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Best-corrected visual acuity (logarithm of the minimum angle of resolution) at 6 months after treatment
Key secondary outcomes
Best-corrected visual acuity (logMAR) at 1,3 months after treatment
Foveal thickness at 1week, 1,3,6 months after treatment
Intraocular pressure at 1,3,6 months after treatment
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
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A single sub-Tenon's injection of triamcinolone acetonide (20mg) and panretinal photocoagulation
Interventions/Control_2
Panretinal photocoagulation
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
Patients with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy, whose retinopathy is bilateral and symmetrical, and panretinal ptotocoagulation is required for.
Key exclusion criteria
(1)Intraocular pressure is more than 21 mmHg
(2)Massive cataract
(3)Ocular pathology other than diabetic retinopathy (e.g., glaucoma, age-related macular degeneration)
(4)Tractional retinal detachment or massive proliferation
(5)Vitreous hemorrhage
(6)Unilateral or asymmetrical diabetic retinopathy
(7)Neovascular glaucoma
(8)Previous vitreoretinal surgery
(9)Previous panretinal photocoagulation
(10)Pregnant or lactating women
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mihori Kita |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3250
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Unoki |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3250
Homepage URL
noriharu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of Ophthalmology
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 07 | Month | 27 | 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
| 2006 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 07 | Month | 27 | Day |
Last modified on
| 2009 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000553
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