UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between choroidal structure and protein uria in patients with diabetetic macular edema
Acronym	Choroidal structure in patients with diabetic macular edema and protein uria
Scientific Title	The relationship between choroidal structure and protein uria in patients with diabetetic macular edema
Scientific Title:Acronym	Choroidal structure in patients with diabetic macular edema and protein uria
Region	Japan

Condition
Condition	diabetic retinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine relationship between the choroidal structure on EDI-OCT images and urine protein to creatinine ratio in patients with diabetic maculapathy.
Basic objectives2	Others
Basic objectives -Others	To examine the influence of protein uria on the efficacy of the treatment for diabetic macular edema
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Choroidal structural paremeters on EDI-OCT images and urine protein to creatinine ratio
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Intravitreal injections of anti-vasular endothelial growth factor agents under treatment regimen with the maximum frequency of monthly injections. Observation with or without interventions are to be performed for 12 months.
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	ETDRS retinal central subfield thickness of >300 micrometer and best-correced visual acuity of >0.05
Key exclusion criteria	Patients or eyes with following conditions are to be excluded. 1. patients under hemodialysis 2. previous vitrectomy 3. intraocular surgeries including retinal photocoagulations within 3 months at the time of enrollment 4. high myopia 5. intraocluar pressure of >24 mmHg 6. visual impairment with any causes other than diabetic macular edema 7. uncontrolled hypertension
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroko Middle name Last name Imaizumi
Organization	Sappro City General Hospial
Division name	Department of Ophthalmology
Zip code	060-8604
Address	1-1, North 11, West 13, Sapporo, 060-8604, Japan
TEL	+81-11-726-2211
Email	hiroko.imaizumi@doc.city.sapporo.jp

Public contact
Name of contact person	1st name Takamasa Middle name Last name Kinoshita
Organization	Sappro City General Hospial
Division name	Department of Ophthalmology
Zip code	060-8604
Address	1-1, North 11, West 13, Sapporo, 060-8604, Japan
TEL	+81-11-726-2211
Homepage URL
Email	knst129@gmail.com

Sponsor
Institute	Sappro City General Hospial
Institute
Department

Funding Source
Organization	Sappro City General Hospial
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	Sappro City General Hospial
Address	1-1, North 11, West 13, Sapporo, 060-8604, Japan
Tel	81 11 826 2211
Email	masatoshi.moria@city.sapporo.jp

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	市立札幌病院眼科、徳島大学大学院医歯薬研究部眼科学分野

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 10 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	200
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	Main results already published
Date of protocol fixation	2017 Year 01 Month 25 Day
Date of IRB	2017 Year 02 Month 06 Day
Anticipated trial start date	2017 Year 02 Month 13 Day
Last follow-up date	2020 Year 12 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	2017 Year 02 Month 07 Day
Last modified on	2020 Year 02 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029726

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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