UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research of the effect and the safety with 0.1% bromfenac sodium hydrate ophthalmic solution and 0.1% betamethasone sodium phosphate ophthalmic, otic and nasal solution in patients with diabetic macular edema
Title of the study (Brief title)	The effect and the safety with 0.1% bromfenac ophthalmic solution and 0.1% betamethasone ophthalmic solution in patients with 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 of this study is to investigate the therapy for mild DME with 0.1% bromfenac sodium hydrate ophthalmic solution using OCT quantitative assay.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change value of the central macular thickness at 12 weeks after starting administration of test drug from that at the day of starting administration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.1% bromfenac sodium hydrate ophthalmic solution
Interventions/Control_2	0.1% betamethasone sodium phosphate ophthalmic , otic and nasal solution
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	On screening 1)Patients with DME 2)Patients with HbA1c value less than 10% 3)Patients with visual acuity more than 0.5 On starting administration 4)Patients with 250-500 of central macular thickness
Key exclusion criteria	On screening (1)Topical 1)Patients with severe diabetic retinopathy or DME who need IVT injection of VEGF inhibitor, retinal photocoagulation, or vitreous surgery 2)Patients with a history of hypersensitivity against components of test drugs 3)Patients with retinochoroidal disease except for diabetic retinopathy or DME 4)Patients with uveitis 5)Patients with glaucoma 6)Patients with previous vitreous surgery 7)Patients who received retinal photocoagulation or cataract surgery within 6 months before starting administration of test drugs 8)Patients who received systemic or topical administration of steroid, IVT injection of VEGF inhibitor within 1 month, or hyperbaric oxygen therapy within 6 months before starting administration of test drugs 9)Patients with excessive myopia less than -6D 10)Patients with a history of hypersensitivity against fluorescein for fluorescent fundus angiography 11)Patients unable to tolerate OCT measurement (2)Systemic 12)Patients with cancer, severe hepatopathy ,nephropathy, cardiovascular disease, or endocrine system disease, who was judged to be inappropriate as a subject by doctor in charge 13)Pregnant, lactating, or possible pregnant woman On screening and baseline (1)Topical 14)Complete loss of ELM or IS/OS line in macular OCT tomography with the eye for effect evaluation 15)Patients with subretinal fluid in macular OCT tomography 16)Patients who has cloudy cyst with possible influence to improvement of visual acuity in macular OCT tomography (3)Other 17)Patients who was judged to be inappropriate as a subject by doctor
Target sample size	20

Research contact person
Name of lead principal investigator	Shigehiko Kitano
Organization	Diabetes Center Tokyo Womens Medical University School of Medicine
Division name	Ophthalmology
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	hayashi@oph.twmu.ac.jp

Public contact
Name of contact person	Rie Hayashi
Organization	Tokyo Womens Medical University School of Medicine
Division name	Ophthalmology
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	hayashi@oph.twmu.ac.jp

Sponsor
Institute	Diabetes Center Tokyo Womens Medical University School of Medicine
Institute
Department

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	東京女子医科大学糖尿病センター(東京都)

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 26 Day
Anticipated trial start date	2017 Year 02 Month 18 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	2017 Year 02 Month 17 Day
Last modified on	2017 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030098