UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema
Acronym	Simultaneous subthreshold retinal-photocoagulation and intravitreal injection of VEGFinhibitors for DME
Scientific Title	Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema
Scientific Title:Acronym	Simultaneous subthreshold retinal-photocoagulation and intravitreal injection of VEGFinhibitors for DME
Region	Japan

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

Objectives
Narrative objectives1	Eyes received either intravitreal VEGF inhibitors injection independent therapy or combination therapy of VEGF inhibitors and subthreshold photocoagulation. A purpose of this study is to evaluate whether we can reduce the number of the dosage of the VEGF inhibitors by combination therapy, and to examine the effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A period before re-injection : A period before re-injection being necessary after the 3 consecutive monthly intravitreal injection of VEGF inhibitors
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	intravitreal injection of VEGF inhibitors
Interventions/Control_2	intravitreal injection of VEGF inhibitors subthreshold retinal-photocoagulation
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Japanese male and female >= 18 years with type 1 or 2 diabetes mellitus 2) DME with central involvementin the study eye 3) Decrease in vision determined to be primarily the result of DME in the study eye 4) central macular thickness >= 300um in the study eye 5)BCVA of 0.7 to 0.05 in the study eye
Key exclusion criteria	Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1 Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1 Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days of day 1 Active proliferative diabetic retinopathy (PDR) in the study eye Uncontrolled diabetes mellitus
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shuichi Middle name Last name Yamamoto
Organization	Chiba University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
TEL	043-222-7171
Email	shuyama@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Tomoaki Middle name Last name Tatsumi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	ttatsumi@chiba-u.jp

Sponsor
Institute	Department of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Bayer Yakuhin Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chiba Univeratiy Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
Tel	043-226-2616
Email	prc-jim@chiba-u.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs031180182
Org. issuing International ID_1	Japan Registry of Clinical Trialas
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉大学医学部附属病院（千葉県）、千葉ろうさい病院（千葉県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 09 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	51
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	Completed
Date of protocol fixation	2015 Year 10 Month 14 Day
Date of IRB	2015 Year 07 Month 21 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 11 Month 04 Day
Last modified on	2022 Year 05 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022341