UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015162 |
|---|---|
| Receipt number | R000017632 |
| Scientific Title | Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion |
| Date of disclosure of the study information | 2014/09/16 |
| Last modified on | 2020/05/27 14:30:08 |
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Basic information
Public title
Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Acronym
Efficacy of intravitreal injection of aflibercept for retinal vein occlusion
Scientific Title
Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Scientific Title:Acronym
Efficacy of intravitreal injection of aflibercept for retinal vein occlusion
Region
| Japan |
Condition
Condition
retinal vein occulusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Basic objectives2
Others
Basic objectives -Others
Analysis of the association between the pathology and the factor of aqueous humor in eyes with retinal vein occlusion
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Analysis of the factor concerning the variation of best-corrected visual acuity 1 year after the first intravitreal injection
Key secondary outcomes
Analysis of the factor concerning the variation of best-corrected visual acuity and the regression of macular edema 2 year after the first intravitreal injection
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
interavitreal injection of 2.0mg of aflibercept
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
Patients with visual impairments due to macular edema associated with retinal vein oclusion
Key exclusion criteria
Patients with difficulty in intravitreal injection and examination because of mental retardation or dementia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsujikawa Akitaka |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3248
tujikawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Muraoka |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3248
Homepage URL
muraoka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 09 | Month | 16 | 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
| 2014 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 08 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2020 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017632
