UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005648 |
|---|---|
| Receipt number | R000005566 |
| Scientific Title | Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema |
| Date of disclosure of the study information | 2011/05/31 |
| Last modified on | 2012/07/04 11:50:57 |
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Basic information
Public title
Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema
Acronym
Efficacy and Safety of SJE-2079 for Diabetic Macular Edema
Scientific Title
Phase II study of Efficacy and Safety of SJE-2079 in the Treatment for Diabetic Macular Edema
Scientific Title:Acronym
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Diagnosis of type 2 diabetes mellitus
2)Non-proliferative diabetic retinopathy for study eyes
3)Best corrected visual acuity in the efficacy evaluation-intended eye of 30-80 EDTRS letters
4)OCT retinal thickness at center point in the efficacy evaluation-intended eye of >=350 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
4)HbA1c of >=10.0%
5)Instillation of any corticosteroid, nonsteroidal anti-inflammatory drug or carbonic anhydrase inhibitor within 4 weeks
6)Systemic administration of any corticosteroid within 4 weeks
7)Macular photocoagulation, injection of corticosteroid or any affective drug into the vitreous, sub-tenon capsule and sub-conjunctiva, vitreous surgery, hyperbaric oxygen therapy, stellate ganglion block, cataract surgery or other intraocular surgery within 24 weeks
8)Retinal photocoagulation except macular area within 4 weeks
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Terai |
Organization
Senju Pharmaceutical co.,ltd.
Division name
Clinical Development Div.
Zip code
Address
2-5-8,Hirano-machi, Chuo-ku, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Senju Pharmaceutical co.,ltd.
Division name
Clinical Development Div.
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Clinical Development Div., Senju Pharmaceutical co.,ltd.
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
None
Name of secondary funder(s)
None
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | 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
| 2011 | Year | 05 | Month | 26 | Day |
Last modified on
| 2012 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005566
