UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema
Title of the study (Brief title)	Efficacy and Safety of SJE-2079 for Diabetic Macular Edema
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of SJE-2079 comparing vehicle in the treatment for diabetic macular edema
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean change from baseline in retinal central foveal thickness using optical coherence tomography (OCT)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SJE-2079 BID group: One drop of SJE-2079 instilled in the affected eye(s) twice a day, and 1 drop of vehicle instilled in the same eye(s) twice a day.
Interventions/Control_2	SJE-2079 QID group: One drop of SJE-2079 instilled in the affected eye(s) 4 times a day.
Interventions/Control_3	Vehicle group: One drop of vehicle instilled in the affected eye(s) 4 times a day.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Diabetic macular edema for study eyes 2)Best corrected visual acuity in the efficacy evaluation-intended eye of 30-80 EDTRS letters 3)OCT retinal thickness at center point in the efficacy evaluation-intended eye of 250-600 microns
Key exclusion criteria	1)Active and serious retinal disease 2)History of steroid-induced elevation of IOP 3)Any active ocular disease other than diabetic retinopathy
Target sample size	90

Research contact person
Name of lead principal investigator	Hidetoshi Yamashita
Organization	Yamagata University Faculty of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	2-2-2 Iida-Nishi, Yamagata-shi
TEL	023-633-1122
Email	hyama-tky@umin.ac.jp

Public contact
Name of contact person	Yoko Minagawa
Organization	Senju Pharmaceutical co.,ltd.
Division name	Strategic Development Group, Regulatory Science Div.
Address	2-5-8,Hirano-machi, Chuo-ku, Osaka
TEL	06-6201-9605
Homepage URL
Email	yoko_minagawa@senju.co.jp

Sponsor
Institute	Senju Pharmaceutical co.,ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Senju Pharmaceutical co.,ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2013 Year 09 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
Anticipated trial start date	2013 Year 09 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

Management information
Registered date	2013 Year 09 Month 26 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013623