UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020078 |
|---|---|
| Receipt number | R000023198 |
| Scientific Title | Biochemical analysis of cell death molecules in vitreous and aqueous humor of neurodegenerative disease in retina and optic nerve |
| Date of disclosure of the study information | 2015/12/05 |
| Last modified on | 2015/12/05 08:35:08 |
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Basic information
Public title
Biochemical analysis of cell death molecules in vitreous and aqueous humor of neurodegenerative disease in retina and optic nerve
Acronym
Biochemical analysis of cell death molecules in vitreous and aqueous humor
Scientific Title
Biochemical analysis of cell death molecules in vitreous and aqueous humor of neurodegenerative disease in retina and optic nerve
Scientific Title:Acronym
Biochemical analysis of cell death molecules in vitreous and aqueous humor
Region
| Japan |
Condition
Condition
glaucoma, retinal detachment, branch retinal vein occulusion, diabetic retinopathy, epiretinal membrane, macula hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the cell death molecules in neurodegenerative disease in retina and optic neuropathy.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Biological and clinical equivalence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Gene |
Interventions/Control_1
The control is epiretinal membrane
Interventions/Control_2
Glaucoma
Interventions/Control_3
Branch retinal Vein Occulusion
Interventions/Control_4
retinal detachment
Interventions/Control_5
macula hole
Interventions/Control_6
diabetic retinopathy
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
not paticular
Key exclusion criteria
not paticular
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunari Munemasa |
Organization
St Marianna University School of Medicine
Division name
Ophthalmology
Zip code
Address
2-16-1 sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
0449778111
munemasa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunari Munemasa |
Organization
St marianna University School of Medicine
Division name
Ophthalmology
Zip code
Address
2-16-1 sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
0449778111
Homepage URL
munemasa@marianna-u.ac.jp
Sponsor or person
Institute
St marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant in aid for scientific research fund
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | 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
| 2015 | Year | 12 | Month | 05 | Day |
Last modified on
| 2015 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023198
