UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026201 |
|---|---|
| Receipt number | R000030098 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2017/02/18 |
| Last modified on | 2017/02/17 21:48:04 |
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Basic information
Public title
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
Acronym
The effect and the safety with 0.1% bromfenac ophthalmic solution and 0.1% betamethasone ophthalmic solution in patients with diabetic macular edema
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shigehiko Kitano |
Organization
Diabetes Center
Tokyo Womens Medical University School of Medicine
Division name
Ophthalmology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
hayashi@oph.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Hayashi |
Organization
Tokyo Womens Medical University School of Medicine
Division name
Ophthalmology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
hayashi@oph.twmu.ac.jp
Sponsor or person
Institute
Diabetes Center
Tokyo Womens Medical University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030098
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