UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003376 |
|---|---|
| Receipt number | R000004102 |
| Scientific Title | Clinical studies in the association with retina vitreous disease and intraocular cytokine |
| Date of disclosure of the study information | 2010/03/25 |
| Last modified on | 2013/04/10 14:31:33 |
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Basic information
Public title
Clinical studies in the association with retina vitreous disease and intraocular cytokine
Acronym
Clinical studies in the association with retina vitreous disease and intraocular cytokine
Scientific Title
Clinical studies in the association with retina vitreous disease and intraocular cytokine
Scientific Title:Acronym
Clinical studies in the association with retina vitreous disease and intraocular cytokine
Region
| Japan |
Condition
Condition
retina vitreous disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relation between retina vitreous disease and intraocular cytokines.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of intraocular cytokines
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
vitrectomy
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
| 43 | years-old | <= |
Age-upper limit
| 87 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. clinically detectable diffuse macular edema or cystoid macular edema that had persisted for more than 3 months
2. best-corrected visual acuity worse than 20/40
3. persistence of macular edema despite retinal photocoagulation
Key exclusion criteria
1. previous ocular or vitreous injection of anti-VEGF agent
2. diabetic retinopathy
3. history of ocular inflammation
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetaka Noma |
Organization
Yachiyo Medical Center, Tokyo Womens Medical University
Division name
Department of Ophthalmology
Zip code
Address
477-96, Owada-shinden, Yachiyo, Chiba
TEL
047-450-6000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetaka Noma |
Organization
Yachiyo Medical Center, Tokyo Womens Medical University
Division name
Department of Ophthalmology
Zip code
Address
477-96, Owada-shinden, Yachiyo, Chiba
TEL
047-450-6000
Homepage URL
nomahide@tymc.twmu.ac.jp
Sponsor or person
Institute
Yachiyo Medical Center, Tokyo Womens Medical University
Institute
Department
Personal name
Funding Source
Organization
Yachiyo Medical Center, Tokyo Womens 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
| 2010 | Year | 03 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | 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
| 2010 | Year | 03 | Month | 25 | Day |
Last modified on
| 2013 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004102
| 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 |
