UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019837 |
|---|---|
| Receipt number | R000022916 |
| Scientific Title | Analysis of inflammatory cells, soluble factors, molecules as mediators of retinal neural dysfunction and death |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2015/12/08 18:45:56 |
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Basic information
Public title
Analysis of inflammatory cells, soluble factors, molecules as mediators of retinal neural dysfunction and death
Acronym
Analysis of molecular mechanisms of retinal neural dysfunction
Scientific Title
Analysis of inflammatory cells, soluble factors, molecules as mediators of retinal neural dysfunction and death
Scientific Title:Acronym
Analysis of molecular mechanisms of retinal neural dysfunction
Region
| Japan |
Condition
Condition
retinal dysfunction, retinal degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the causes of dysfunction or death of retinal neurons.
Basic objectives2
Others
Basic objectives -Others
Analysis of pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether one can replicate the pathology in mice using patient's serum.
Key secondary outcomes
Identification of autoantigen for autoimmune retinopathy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Retinal degenration with little pigmentation or atypical Retinal degeneration or retinal degeneration with causative mutations unidentified.
Intraocular inflammation.
Patient strongly suspected of having reduced vision, signs of retinal structual or electrophysiological abnormalities.
Key exclusion criteria
patients that were judged to be inappropriated by the physician.
Intraocular surgery within 2 weeks.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Ophthalmic Medicine
Zip code
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL
+81-22-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KOJI Nishiguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Ophthalmic Medicine
Zip code
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL
+81-22-717-7294
Homepage URL
nishiguchi@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japanese governmental grant
Donation
Grants
AMED
Organization
Division
Category of Funding 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
We are optimizing the experimental conditions.
We are also collecting samples.
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
| 2014 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Experimental design: case control study
Subjects: Those who fulfilled the inclusion criteria
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2015 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022916
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
