UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study for the effect of intravitreous injection of ranibizumab (product name: Lucentis) and subthreshold laser photocoagulation on diabetic macular edema
Title of the study (Brief title)	The study for the effect of combination therapy of intravitreous injection of ranibizumab and subthreshold laser photocoagulation on diabetic macular edema
Region	Japan

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

Objectives
Narrative objectives1	The purpose is to evaluate the effect of combination therapy of intravitreous injection of ranibizumab and subthreshold laser photocoagulatioin on diabetic macular edema.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	best-corrected visual acuity (before treatment, 3 months later, 6 months later, 12 months later) total number of injections (for 12 months) change in central retinal subfield thickness (3 months later, 6 months later, 12 months later)
Key secondary outcomes	fluorescein angiography (before treatment, 3 months later, 6 months later, 12 months later)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Intravitreous injection of ranibizumab Patients receive 3 initial consecutive monthly injections of ranibizumab. Additional injections are performed as needed.
Interventions/Control_2	Combination therapy of intravitreous injection of ranibizumab and subthreshold laser photocoagulation Patients receive subthreshold laser photocoagulation 2 weeks after the first injection of ranibizumab. Patients receive 3 initial consecutive monthly injections of ranibizumab. Additional injections are performed as needed.
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	Best corrected-visual acuity measured with a Landolt chart is 0.7 or less than 0.7. HbA1c is less than 10%. Over 3 months must pass since glycemic control begins.
Key exclusion criteria	Patients who receive occular surgical treatments within 3 months Patients who receive other macular diseases
Target sample size	100

Research contact person
Name of lead principal investigator	FUMIHIKO TOYODA
Organization	Jichi Medical University, Saitama Medical Center
Division name	Department of Ophthalmology
Address	1-847Amanuma-cho, Omiya-ku,Saitama, Saitama, 330-8503, Japan
TEL	048-647-2111
Email	ft80@jichi.ac.jp

Public contact
Name of contact person	AKIRA YANAI
Organization	Jichi Medical University, Saitama Medical Center
Division name	General Affairs Division
Address	1-847Amanuma-cho, Omiya-ku,Saitama, Saitama, 330-8503, Japan
TEL	048-647-2111
Homepage URL
Email	yanaiakr@jichi.ac.jp

Sponsor
Institute	Jichi Medica University, Saitama Medical Center
Institute
Department

Funding Source
Organization	TOPCON CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Miyacho Ophthalmic Clinic, Shinkoukai medical corporation
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	自治医科大学附属さいたま医療センター

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 26 Day
Anticipated trial start date	2015 Year 04 Month 23 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 11 Month 30 Day
Date trial data considered complete	2018 Year 02 Month 28 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 03 Day
Last modified on	2017 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019751