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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000907
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute the Department of Ophthalmology, University of Tokyo School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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