UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016657 |
|---|---|
| Receipt number | 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 15:46:03 |
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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
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
azuma-n@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019335
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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