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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026033
Receipt No. R000029726
Scientific Title The relationship between choroidal structure and protein uria in patients with diabetetic macular edema
Date of disclosure of the study information 2017/02/10
Last modified on 2019/02/09

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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
Middle name
Last name Hiroko Imaizumi
Organization Sappro City General Hospial
Division name Department of Ophthalmology
Zip code
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
Middle name
Last name Takamasa Kinoshita
Organization Sappro City General Hospial
Division name Department of Ophthalmology
Zip code
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
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 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
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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 02 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
2017 Year 02 Month 07 Day
Last modified on
2019 Year 02 Month 09 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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