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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013975
Receipt No. 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

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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
Email 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
Email nonobe@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University hospital ophtalmoligy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016281

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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