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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005778
Receipt No. R000006831
Scientific Title Clinical study about ophthalmic local administrations of Triamcinolone acetonide for macular edema and/or retinal periphlebitis
Date of disclosure of the study information 2011/06/14
Last modified on 2017/12/25

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Basic information
Public title Clinical study about ophthalmic local administrations of Triamcinolone acetonide for macular edema and/or retinal periphlebitis
Acronym Clinical study about ophthalmic local administrations of Triamcinolone acetonide
Scientific Title Clinical study about ophthalmic local administrations of Triamcinolone acetonide for macular edema and/or retinal periphlebitis
Scientific Title:Acronym Clinical study about ophthalmic local administrations of Triamcinolone acetonide
Region
Japan

Condition
Condition macular edema and/or retinal periphlebitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of ophthalmic local administration of Triamcinolone acetonide.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual acuity and retinal thickness
Key secondary outcomes

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
Interventions/Control_1 ophthalmic local administration of Triamcinolone acetonide
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with extended macular edema and/or retinal periphlebitis
Key exclusion criteria anaphylaxis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Yamashita
Organization Yamagata University School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address Iidanishi 2-2-2,Yamagata, Yamagata
TEL 023-628-5374
Email hyama-tkt@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachi Abe
Organization Yamagata University School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address iidanishi2-2-2, Yamagata, Yamagata
TEL 023-628-5374
Homepage URL
Email milkydog329@dc5.so-net.ne.jp

Sponsor
Institute Department of Ophthalmology and Visual Sciences, Yamagata University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology and Visual Sciences, Yamagata University School of Medicine
Organization
Division
Category of Funding Organization
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
2011 Year 06 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially 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 Enrolling by invitation
Date of protocol fixation
2006 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 13 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
2011 Year 06 Month 14 Day
Last modified on
2017 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006831

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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