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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016657
Receipt No. R000019335
Scientific Title Dose finding study on safety and efficacy of Anti-VEDF drugs for treatment for treatment of retinopathy of prematurity
Date of disclosure of the study information 2015/02/27
Last modified on 2015/02/27

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Basic information
Public title Dose finding study on safety and efficacy of Anti-VEDF drugs for treatment for treatment of retinopathy of prematurity
Acronym Dose finding study on Anti-VEDF drugs for retinopathy of prematurity
Scientific Title Dose finding study on safety and efficacy of Anti-VEDF drugs for treatment for treatment of retinopathy of prematurity
Scientific Title:Acronym Dose finding study on Anti-VEDF drugs for retinopathy of prematurity
Region
Japan

Condition
Condition retinopathy of prematurity
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine safe and effective dose of Anti-VEDF drugs for treatment for treatment of retinopathy of prematurity.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stabilization of retinopathy of prematurity and safety
Key secondary outcomes

Base
Study type

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 anti-VEDF drugs
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
4 weeks-old <=
Age-upper limit
12 weeks-old >=
Gender Male and Female
Key inclusion criteria retinopathy of prematurity with progressive neovascular proliferation despite photocoagulation therapy
Key exclusion criteria progressive retinal detachment
wide area of neovascular proliferation
aggressive posterior retinopathy of prematurity
systemic abnormalities
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Azuma
Organization National Center for Child Health and Development
Division name Department of Ophthalmology & Laboratory for Visual Science
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181
Email azuma-n@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Azuma
Organization National Center for Child Health and Development
Division name Department of Ophthalmology & Laboratory for Visual Science
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181
Homepage URL
Email azuma-n@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization National Center for Child Health and Development
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Metropolitan Bokutoh Hospital
Tokyo Metropolitan Ohtsuka Hospital
Tokyo Metropolitan Children's Medical Center
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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 27 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 Preinitiation
Date of protocol fixation
2015 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 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 02 Month 27 Day
Last modified on
2015 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019335

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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