UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020078
Receipt number R000023198
Scientific Title Biochemical analysis of cell death molecules in vitreous and aqueous humor of neurodegenerative disease in retina and optic nerve
Date of disclosure of the study information 2015/12/05
Last modified on 2015/12/05 08:35:08

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Basic information

Public title

Biochemical analysis of cell death molecules in vitreous and aqueous humor of neurodegenerative disease in retina and optic nerve

Acronym

Biochemical analysis of cell death molecules in vitreous and aqueous humor

Scientific Title

Biochemical analysis of cell death molecules in vitreous and aqueous humor of neurodegenerative disease in retina and optic nerve

Scientific Title:Acronym

Biochemical analysis of cell death molecules in vitreous and aqueous humor

Region

Japan


Condition

Condition

glaucoma, retinal detachment, branch retinal vein occulusion, diabetic retinopathy, epiretinal membrane, macula hole

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To investigate the cell death molecules in neurodegenerative disease in retina and optic neuropathy.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Biological and clinical equivalence

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Gene

Interventions/Control_1

The control is epiretinal membrane

Interventions/Control_2

Glaucoma

Interventions/Control_3

Branch retinal Vein Occulusion

Interventions/Control_4

retinal detachment

Interventions/Control_5

macula hole

Interventions/Control_6

diabetic retinopathy

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

not paticular

Key exclusion criteria

not paticular

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasunari Munemasa

Organization

St Marianna University School of Medicine

Division name

Ophthalmology

Zip code


Address

2-16-1 sugao, Miyamae, Kawasaki, Kanagawa, Japan

TEL

0449778111

Email

munemasa@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasunari Munemasa

Organization

St marianna University School of Medicine

Division name

Ophthalmology

Zip code


Address

2-16-1 sugao, Miyamae, Kawasaki, Kanagawa, Japan

TEL

0449778111

Homepage URL


Email

munemasa@marianna-u.ac.jp


Sponsor or person

Institute

St marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Grant in aid for scientific research fund

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 05 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

Open public recruiting

Date of protocol fixation

2013 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2013 Year 11 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 12 Month 05 Day

Last modified on

2015 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023198


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name