UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013684 |
|---|---|
| Receipt number | R000015974 |
| Scientific Title | Influence of intraocular, serum, and urinary cytokine and metabolic products on the pathogenesis of age-ralated ocular diseases. |
| Date of disclosure of the study information | 2014/04/10 |
| Last modified on | 2016/04/11 08:31:13 |
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Basic information
Public title
Influence of intraocular, serum, and urinary cytokine and metabolic products on the pathogenesis of age-ralated ocular diseases.
Acronym
Cytokine and metabolic products in age-ralated ocular disease
Scientific Title
Influence of intraocular, serum, and urinary cytokine and metabolic products on the pathogenesis of age-ralated ocular diseases.
Scientific Title:Acronym
Cytokine and metabolic products in age-ralated ocular disease
Region
| Japan |
Condition
Condition
Cataract, glaucoma, age related macula degeneration, diabetic retinopthy, retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate molecules such as metabolic products in patients with age-related ocular disease.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular, serum, and urinary levels of various cytokines, and metabolic products.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Operation and intraocular injection of drugs
Interventions/Control_2
no-treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with cataract, glaucoma, age related macula degeneration, diabetic retinopthy, retinal vein occlusion.
Key exclusion criteria
Patients without agreement for study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Mimura |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Ophthalmology
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo, 116-8567 Japan
TEL
03-3810-1111
mimurat-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Mimura |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Ophthalmology
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo, 116-8567 Japan
TEL
03-3810-1111
Homepage URL
mimurat-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Medical Center East
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 04 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 10 | 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
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015974
