UMIN-CTR Clinical Trial

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	No longer recruiting
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 08 Month 05 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	2022 Year 04 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041494