UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014505 |
|---|---|
| Receipt number | R000016874 |
| Scientific Title | Efficacy of aflibercept for Macular edema secondary to central retinal vein occlusion (CRVO) |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2014/07/08 12:37:18 |
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Basic information
Public title
Efficacy of aflibercept for Macular edema secondary to central retinal vein occlusion (CRVO)
Acronym
Investigation of Eylea for CRVO
Scientific Title
Efficacy of aflibercept for Macular edema secondary to central retinal vein occlusion (CRVO)
Scientific Title:Acronym
Investigation of Eylea for CRVO
Region
| Japan |
Condition
Condition
central retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of aflibercept on VA and anatomic outcomes of treatment-naive patients with ME due to CRVO.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VA change from baseline to month 12
Change of retinal thickness, chroidal thickness and edema from baseline to month 12
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
Eylea (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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with ME due to CRVO
2)Retinal thickness 300um and over
3)BCVA in the study eye between 0.1 to 1.0(Decimal VA)
4)Adults 20 years and older
5)Willomgness to provide written informed consent.
Key exclusion criteria
1) The following exclusions apply to the study eye only.
Prior treatment with steroids (<3 months)
History of vitrectomy surgery, submacular surgery, or other surgical intervention.
2) Active intraocular inflammation.
3) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products, or to any of the study drugs or their components.
4) pregnant women and nursing mothers.
5) Patient who the doctor in charge judges are ineligible for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitoshi Yodhida |
Organization
Asahikawa Medical University
Division name
Department of Ophthalmology
Zip code
Address
1-1-1 2jo, Midorigaokahigashi, Asahikawa
TEL
0166-65-2111
cdh72740@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Sogawa |
Organization
Asahikawa Medical University
Division name
Department of Ophthalmology
Zip code
Address
1-1-1 2jo, Midorigaokahigashi, Asahikawa
TEL
0166-65-2111
Homepage URL
cdh72740@yahoo.co.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
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
| 2014 | Year | 07 | Month | 08 | 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 | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2014 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016874
