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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032946
Receipt No. R000011589
Scientific Title Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration, diabetic retinopathy, and central serous chorioretinopathy
Date of disclosure of the study information 2018/06/11
Last modified on 2019/06/12

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Basic information
Public title Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration,
diabetic retinopathy, and central serous chorioretinopathy
Acronym Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration,
diabetic retinopathy, and central serous chorioretinopathy
Scientific Title Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration,
diabetic retinopathy, and central serous chorioretinopathy
Scientific Title:Acronym Analyses of serum concentrations of inflammatory cytokines, fatty acids, and oxidation products in the patients with age-related macular degeneration,
diabetic retinopathy, and central serous chorioretinopathy
Region
Japan

Condition
Condition age-related macular degeneration, diabetic retinopathy, central serous chorioretinopathy
Classification by specialty
Ophthalmology Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship of the serum cytokine levels, fatty acid, and oxidation products with age-related macular degeneration and diabetic retinopathy, and central serous chorioretinopathy
Basic objectives2 Others
Basic objectives -Others serum cytokine levels, fatty acid, and oxidation products
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes serum levels of cytokine , fatty acid, and oxidation products and patients age, severity of the diseases
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
50 years-old <=
Age-upper limit
120 years-old >
Gender Male and Female
Key inclusion criteria patients with age-related macular degeneration or diabetic retinopathy
central serous chorioretinopathy
control: Patients without age-related macular degeneration, diabetic retinopathy, and any other inflammatory diseases.
Key exclusion criteria Patient intaking Omega-3 supplements or medications
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Kaneko
Organization Nagoya University Hospital Dept. of Ophthalmology
Division name Ophthalmology
Zip code 4668550
Address 65 Tsurumai, Showa-ku, Nagoya
TEL 052-744-2277
Email h-kaneko@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Kaneko
Organization Nagoya University Hospital
Division name Ophthalmology
Zip code 4668550
Address 65 Tsurumai, Showa-ku, Nagoya
TEL 052-744-2277
Homepage URL http://www.med.nagoya-u.ac.jp/ganka/
Email h-kaneko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Dept. of Ophthalmology
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Nagoya University Hospital
Address 65 Tsurumai, Showa-ku, Nagoya
Tel 052-744-2061
Email ethics@med.nagoya-u.ac.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 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 11 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 11 Day
Date of IRB
2018 Year 03 Month 23 Day
Anticipated trial start date
2018 Year 06 Month 11 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information na

Management information
Registered date
2018 Year 06 Month 11 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011589

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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