UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	How to prevent vascular infarction due to anti-VEGF treatment for DME
Title of the study (Brief title)	Vascular infarction due to anti-VEGF treatment for DME
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether the value of bio markers which reflects vascular infarction during anti VEGF treatment for diabetic macular edema (DME).
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentration of various cytokines
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Type I and II DM patients over 20 yrs old with IC. 2)Clinically Significant Macular Edema (CSME) with diffuse macular edema which cannnot treat only with photocoagulation (PC). 3)VA disturbances not due to diabetic retinopathy but DME. 4)LogMAR BCVA between 1.52 and 1.22. 5)Central mretinal thickness >300 micro meter within 1mm of OCT retinal map..
Key exclusion criteria	1)Received PC treatment within 3 months. 2)Ischemic maculopathy. 3)Vitreo-macular traction syndrome. 4)Active diabetic retinopathy. 5)Any history of glaucoma. 6)Any history of optic neuropathy, 7)Any history of vitrectomy, 8)Vitreal or sub-tenon injections within 3 months before treatment. 10) Cataract surgery within 6 months before treatment.
Target sample size	25

Research contact person
Name of lead principal investigator	Masahiko Sugimoto
Organization	Mie University, School of Medicine
Division name	Department of Ophthalmology
Address	2-174, Edobashi, Tsu, Mie, Japan
TEL	0592315027
Email	sugmochi@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Masahiko Sugimoto
Organization	Mie University, School of Medicine
Division name	Department of Ophthalmology
Address	2-174, Edobashi, Tsu, Mie, Japan
TEL	0592315027
Homepage URL
Email	sugmochi@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Ophthalmology,Mie University, School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology,Mie University, School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 03 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 26 Day
Anticipated trial start date	2014 Year 12 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	During loading phase of intravitreal injection of anti-VEGF drug(monthly),we collect anterior chamber fluid and blood from patients at 1)pre-treatment, 1w after treatment (only blood) and 3)at 2nd injection of anti-VEGF drug. Concentration of various cytokines are evaluated from collected samples.

Management information
Registered date	2016 Year 03 Month 27 Day
Last modified on	2017 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024957