UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022387
Receipt number R000025800
Scientific Title Study on safety and efficacy of Anti-VEDF drugs for treatment for treatment of retinopathy of prematurity
Date of disclosure of the study information 2016/05/20
Last modified on 2016/05/20 15:08:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study on safety and efficacy of Anti-VEDF drugs for treatment for treatment of retinopathy of prematurity

Acronym

Study on Anti-VEDF drugs for retinopathy of prematurity

Scientific Title

Study on safety and efficacy of Anti-VEDF drugs for treatment for treatment of retinopathy of prematurity

Scientific Title:Acronym

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 safety and efficacy 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

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 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

10


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 or person

Institute

Department of Ophthalmology & Laboratory for Visual Science, 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

Other

Nationality of Funding Organization

Japan


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

東京都立墨東病院      
東京都立大塚病院        
東京都立小児医療センター
信州大学病院       
名古屋大学病院      
滋賀医科大学病院     
近畿大学病院     
福岡大学病院
淀川キリスト教病院


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 20 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

Date of protocol fixation

2016 Year 05 Month 16 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 20 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 20 Day

Last modified on

2016 Year 05 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025800


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name