UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013975 |
|---|---|
| Receipt number | R000016281 |
| Scientific Title | Intravitreal injection of anti vascular endothelial growth factor agent, Lucentis (ranibizumab), for the treatment of retinopathy of prematurity |
| Date of disclosure of the study information | 2014/05/19 |
| Last modified on | 2017/12/03 15:14:21 |
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Basic information
Public title
Intravitreal injection of anti vascular endothelial growth factor agent, Lucentis (ranibizumab), for the treatment of retinopathy of prematurity
Acronym
IVR for ROP
Scientific Title
Intravitreal injection of anti vascular endothelial growth factor agent, Lucentis (ranibizumab), for the treatment of retinopathy of prematurity
Scientific Title:Acronym
IVR for ROP
Region
| Japan |
Condition
Condition
retinopathy of prematurity
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we investigate VEGF concentration of serous and aqueous humor before and after intravitreal injecion of Lucentis to establish effect and safety of Lucentis for ROP.
we will compare the result of Avastin injection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
prevention of retinal detachment
serous VEGF concentration
Key secondary outcomes
visual acuity
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 ranibizumab
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
| 0 | years-old | <= |
Age-upper limit
| 0 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
severe cases of retinopathy of prematurity that are not controled after laser photocoagulation
Key exclusion criteria
inflammation around the eye
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norie Nonobe |
Organization
Nagoya auniversity hospital
Division name
ophthalmology
Zip code
Address
65 tsurumai syowa-ku nagoya city
TEL
052-744-2275
nonobe@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norie Nonobe |
Organization
Nagoya university hospital
Division name
ophthalmology
Zip code
Address
65 tsurumai syowa-ku nagoya city
TEL
052-744-2275
Homepage URL
nonobe@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University hospital ophtalmoligy
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 16 | Day |
Last modified on
| 2017 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016281
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| Registered date | File name |
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| Registered date | File name |
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