UMIN-CTR Clinical Trial

Basic information
Public title	Change in aqueous cytokine level after intravitreal anti-VEGF therapy in diabetic macular edema
Acronym	the effect of anti-VEGF therapy on aqueous cytokine level in DME
Scientific Title	Change in aqueous cytokine level after intravitreal anti-VEGF therapy in diabetic macular edema
Scientific Title:Acronym	the effect of anti-VEGF therapy on aqueous cytokine level in DME
Region	Japan

Condition
Condition	diabetic macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the effect of anti-VEGF therapy on aqueous cytokine level.
Basic objectives2	Others
Basic objectives -Others	the relationship between the change of cytokine level and therapeutic effect
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the change in aqueous cytokine level
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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	aqueous humor collection
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	Not applicable
Gender	Male and Female
Key inclusion criteria	DME patients who receive anti VEGF agent.
Key exclusion criteria	treatment history (surgery or photocoagulation) in 3 months. allergy pregnant participating any other study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name masakazu Middle name Last name morioka
Organization	Fukui University
Division name	ophthalmology
Zip code	9101193
Address	shimoaizuki, matsuoka, eiheijicho, Fukui
TEL	0776613111
Email	mmorioka@u-fukui.ac.jp

Public contact
Name of contact person	1st name masakazu Middle name Last name morioka
Organization	Fukui University
Division name	Ophthalmology
Zip code	9101193
Address	shimoaizuki, matsuoka, eiheijicho, Fukui
TEL	0776613111
Homepage URL
Email	mmorioka@u-fukui.ac.jp

Sponsor
Institute	Fukui University
Institute
Department

Funding Source
Organization	None
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	Fukui University IRB
Address	shimoaizuki, matsuoka, eiheijicho, Fukui
Tel	0776613111
Email	mmorioka@u-fukui.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

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 06 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	Open public recruiting
Date of protocol fixation	2021 Year 01 Month 27 Day
Date of IRB	2021 Year 01 Month 27 Day
Anticipated trial start date	2021 Year 01 Month 27 Day
Last follow-up date	2022 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	2021 Year 07 Month 06 Day
Last modified on	2021 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051061