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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036419
Receipt No. R000041494
Scientific Title Exploratory research in the relation between macular edema and cytokines.
Date of disclosure of the study information 2019/05/01
Last modified on 2019/04/05

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Basic information
Public title Exploratory research in the relation between
macular edema and cytokines.
Acronym The relation between macular edema and
cytokines.
Scientific Title Exploratory research in the relation between
macular edema and cytokines.
Scientific Title:Acronym The relation between macular edema and
cytokines.
Region
Japan

Condition
Condition Diabetic macular edema and macular edema
with retinal vein occlusion.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The investigate the relationship between the onset and severity of
macular edema and the type and concentration of cytokines expressed in the anterior aqueous humor and tear fluid.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between macular edema associated with diabetic
retinopathy or retinal vein occlusion and type of
cytokines(cytokine levels in the aqueous humor, tear fluid and blood).
Key secondary outcomes Relationship between cytokine levels and visual acuity, therapeutic
response, retinal thickness, intraocular pressure, visual field, anterior chamber flare value, fundus autofluorescence, OCT, OCT angiograghy and blood test.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Aflibercept(40mg) simple injection
Interventions/Control_2 Treatment-lessness (nomal)
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 whi are outpatients or hospitalized for ophthalmology at
Tokyo Women's Medical College Yachiyo Medical Center.
Patients diagnosed with macular edema associated with diabetic
retinopathy or retinal vein occulusion.
Patients who undergo the intravitreal injection of anti-VEGF drugs or
catacact surgery.
Key exclusion criteria Patients receiving the intravitreal injection of anti-VEGF drugs with in 3 months of sampling.
Patients receiving the injection suspended steroid within 6 months of
sampling.
Patients without light perception.
Patients who undergo the intraocular surgery within 3 months of
sampling.
In addition, patients who the research director judged as
inappropriate as suject.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hideharu
Middle name
Last name Funatsu
Organization Tokyo Women's Medical University Yachiyo Medical center
Division name Opthalmology
Zip code 276-0046
Address 477-96 Owada-Shinden Yachiyo-shi,Chiba Pref. Japan 276-0046
TEL 047-450-600
Email funatsu.hideharu@twmu.ac.jp

Public contact
Name of contact person
1st name Mariko
Middle name
Last name Kano
Organization Tokyo Women's Medical University Yachiyo Medical center
Division name Opthalmology
Zip code 276-0046
Address 477-96 Owada-Shinden Yachiyo-shi,Chiba Pref. Japan 276-0046
TEL 047-450-600
Homepage URL
Email mariko.kano0613@gmail.com

Sponsor
Institute Tokyo Women's Medical University Yachiyo Medical center
Institute
Department

Funding Source
Organization Tokyo Women's Medical University Yachiyo Medical center
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 Tokyo Women's Medical University Yachiyo Medical center
Address 477-96 Owada-Shinden Yachiyo-shi,Chiba Pref. Japan 276-0046
Tel 047-450-6000
Email mariko.kano0613@gmail.com

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
2019 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 12 Day
Date of IRB
2018 Year 10 Month 12 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2023 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
2019 Year 04 Month 05 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041494

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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