UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019771 |
|---|---|
| Receipt number | R000022834 |
| Scientific Title | Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema |
| Date of disclosure of the study information | 2015/11/13 |
| Last modified on | 2017/09/19 16:58:15 |
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Basic information
Public title
Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema
Acronym
Ranibizumab and chorioretinal blood flow
Scientific Title
Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema
Scientific Title:Acronym
Ranibizumab and chorioretinal blood flow
Region
| Japan |
Condition
Condition
Retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate treatment outcomes including BCVA, OCT-findings and chorioretinal hemodynamics by stratified analysis according to the first IVR treatment response on VA and CFT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Population of visual improvemnt after the first intravitreal injection of Ranibizumab.
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
Duration:12months
Quantity:Ramibizumab 0.5mg/injection
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
Patients with macular edema due to retinal vein occlusion who visit Tokyo women's medical university
Central foveal thickness over 250 micron.
Visual acuity over 0.1
Key exclusion criteria
Othe ocular pathology
Past history of brain and myocardial infarction.
Uncontrolled hypertention.
Anti-VEGF treatment for general diseases.
Laser, Anti-VEGF, intravitreal injection of steroid and vitrectomy for ocular pathology.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Iida |
Organization
Tokyo women's Medical University
Division name
Department of Ophthalmology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
iida@oph.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Kogure |
Organization
Tokyo women's Medical University
Division name
Department of Ophthalmology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
kogure.akiko@twmu.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Tokyo women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharmaceuticals Japan
Organization
Division
Category of Funding Organization
Profit 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 | 13 | 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
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 15 | 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
| 2015 | Year | 11 | Month | 13 | Day |
Last modified on
| 2017 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022834
