UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study about ophthalmic local administrations of Triamcinolone acetonide for macular edema and/or retinal periphlebitis
Title of the study (Brief title)	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	Hidetoshi Yamashita
Organization	Yamagata University School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	Iidanishi 2-2-2,Yamagata, Yamagata
TEL	023-628-5374
Email	hyama-tkt@umin.ac.jp

Public contact
Name of contact person	Sachi Abe
Organization	Yamagata University School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2006 Year 07 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006831