UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on the effects of antimicrobial therapy for refractory uveitis due to sarcoidosis.
Acronym	Antimicrobial therapy for uveitis due to sarcoidosis.
Scientific Title	Exploratory study on the effects of antimicrobial therapy for refractory uveitis due to sarcoidosis.
Scientific Title:Acronym	Antimicrobial therapy for uveitis due to sarcoidosis.
Region	Japan

Condition
Condition	Sarcoidosis
Classification by specialty	Medicine in general Pneumology Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the efficacy and safety of oral antibiotics, clarithromycin and miocycline, for uveitis due to sarcoidosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence or exacerbation of ocular inflammation.
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	Oral administration of antibiotics.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) age between 20 and 80 years old. 2) from whom written informed consent could be obtained. 3) Being diagnosed as sarcoidosis, and having active intermediate or posterior uveitis. 4) satisfy more than one of the followings: a) having grade one or more vitreous opacity b) having retinal phlebitis that could be detected by fluorescein angiography. c) having retinal yellow-white lesions that could be recorded by funds photograph.
Key exclusion criteria	satisfy one of the following: 1) having abnormal values by complete blood cell count. 2) having liver or kidney dysfunction. 3) having systemic infectious diseases such as active tuberculosis, hepatitis B, hepatitis C, or syphilis. 4) being allergenic against clarithromycin or minocyclin. 5) those who researcher consider to be not eligible for the study.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Takase
Organization	Tokyo medical and dental university
Division name	Ophthalmology
Zip code
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-6111
Email	h.takase.oph@tmd.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Takase
Organization	Tokyo medical and dental university
Division name	Ophthalmology
Zip code
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-6111
Homepage URL
Email	h.takase.oph@tmd.ac.jp

Sponsor
Institute	Tokyo medical and dental university
Institute
Department

Funding Source
Organization	Tokyo medical and dental university
Organization
Division
Category of Funding Organization	Other
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	2015 Year 07 Month 15 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	Terminated
Date of protocol fixation	2015 Year 07 Month 01 Day
Date of IRB	2019 Year 02 Month 28 Day
Anticipated trial start date	2019 Year 02 Month 28 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 08 Day
Last modified on	2021 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021117