UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000907 |
|---|---|
| Receipt number | R000001033 |
| Scientific Title | Injection of triamicinolone acetonide into the sub-Tenon capsule for treatment of macular edema |
| Date of disclosure of the study information | 2007/11/27 |
| Last modified on | 2007/11/26 14:34:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Injection of triamicinolone acetonide into the sub-Tenon capsule for treatment of macular edema
Acronym
Injection of triamicinolone acetonide into the sub-Tenon capsule for treatment of macular edema
Scientific Title
Injection of triamicinolone acetonide into the sub-Tenon capsule for treatment of macular edema
Scientific Title:Acronym
Injection of triamicinolone acetonide into the sub-Tenon capsule for treatment of macular edema
Region
| Japan |
Condition
Condition
macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess the safety and efficacy of injection of triamcinolone acetonide into the sub-Tenon capsule for treatment of macular edema
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Opptical coherence tomography findings (before and after 1 month and 3 months) and visual acuity (before and after 1 month and 3 months)
Key secondary outcomes
Intraocular pressure and cataract progression (before, after 1 week, 2weeks, 1 month, and 3 months), blood glucose level (daily, before and for 1week after injection), HbA1c (before and after 1 month and 3 months) and blood pressure (before and after 1 week)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
an injection of 12mg or 20mg triamcinolone acetonide into the sub-Tenon capsule
Interventions/Control_2
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
patient with macular edema
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kato |
Organization
University of Tokyo School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Toda |
Organization
University of Tokyo School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL
Homepage URL
Sponsor or person
Institute
the Department of Ophthalmology, University of Tokyo School of Medicine
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
| 2007 | Year | 11 | Month | 27 | 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
Completed
Date of protocol fixation
| 2003 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 26 | Day |
Last modified on
| 2007 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001033
