UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009418 |
|---|---|
| Receipt number | R000011062 |
| Scientific Title | Intraocular Concentrations of Cytokines and Chemokines in Rhegmatogenous Retinal Detachment and the Effect of Intravitreal Triamcinolone Acetonide |
| Date of disclosure of the study information | 2012/11/28 |
| Last modified on | 2012/11/28 15:00:20 |
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Basic information
Public title
Intraocular Concentrations of Cytokines and Chemokines in Rhegmatogenous Retinal Detachment and the Effect of Intravitreal Triamcinolone Acetonide
Acronym
Intraocular Concentrations of Cytokines and Chemokines in Rhegmatogenous Retinal Detachment and the Effect of Intravitreal Triamcinolone Acetonide
Scientific Title
Intraocular Concentrations of Cytokines and Chemokines in Rhegmatogenous Retinal Detachment and the Effect of Intravitreal Triamcinolone Acetonide
Scientific Title:Acronym
Intraocular Concentrations of Cytokines and Chemokines in Rhegmatogenous Retinal Detachment and the Effect of Intravitreal Triamcinolone Acetonide
Region
| Japan |
Condition
Condition
Rhegmatogenous Retinal Detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the role of intravitreal injection of triamcinolone acetonide (IVTA) in preventing photoreceptor apoptosis in eyes with rhegmatogenous retinal detachment (RRD) by measuring cytokine levels in the aqueous humor before and after IVTA.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentrations of 15 soluble factors (three cytokines, seven chemokines, and five growth factors) were determined before IVTA and 1 day after intravitreal injection of triamcinolone acetonide. The association with clinical findings including macular status and visual acuity was then analyzed.
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
| Medicine |
Interventions/Control_1
Intravitreal injection of 4 mg triamcinolone acetonide 1 day before 25 gauge 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criterion was clinically detectable rhegmatogenous retinal detachment.
Key exclusion criteria
The exclusion criteria were prior vitreous surgery or intravitreal injection of triamcinolone acetonide, intravitreal anti-vascular endothelial growth factor, ocular inflammation, and vitreoretinal or optic nerve diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kunikata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Sendai, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
kunikata@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,
Culture, Sports, Science and Technology, Tokyo, Japan
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
| 2012 | Year | 11 | Month | 28 | 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
| 2006 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | 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
| 2012 | Year | 11 | Month | 28 | Day |
Last modified on
| 2012 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011062
