UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012793 |
|---|---|
| Receipt number | R000014945 |
| Scientific Title | Studies on the predictive factors of treatment outcome after intravitreal injection of Lucentis (ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO) |
| Date of disclosure of the study information | 2014/01/10 |
| Last modified on | 2018/05/27 14:27:48 |
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Basic information
Public title
Studies on the predictive factors of treatment outcome after intravitreal injection of Lucentis (ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO)
Acronym
Effect of ranibizumab in eyes with macular edema associated with CRVO
Scientific Title
Studies on the predictive factors of treatment outcome after intravitreal injection of Lucentis (ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO)
Scientific Title:Acronym
Effect of ranibizumab in eyes with macular edema associated with CRVO
Region
| Japan |
Condition
Condition
Central retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and after the treatment. Predictive factors of treatment outcome are statistically 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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, aqueous VEGF concentration, and new flicker electroretinogram (ERG) using skin electrodes
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
Macular edema secondary to CRVO, Central macular thickness > 300 um, Duration after the onset < 12 months
Key exclusion criteria
Any history of previous treatments for CRVO
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineo Kondo |
Organization
Mie University Hospital
Division name
Ophthalmology
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-231-5027
Mineo@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mineo Kondo |
Organization
Mie University Hospital
Division name
Ophthalmology
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-231-5027
Homepage URL
Mineo@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Ophthalmology, Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma Co.
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
YES
Study ID_1
2638
Org. issuing International ID_1
Mie University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | 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=R000014945
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| Registered date | File name |
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| Registered date | File name |
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