UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013686
Receipt number R000015976
Scientific Title The role of sirtuin in the pathogenesis of age-related ocular disease.
Date of disclosure of the study information 2014/04/10
Last modified on 2016/04/11 08:35:48

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Basic information

Public title

The role of sirtuin in the pathogenesis of age-related ocular disease.

Acronym

Sirtuin in the pathogenesis of age-related ocular disease.

Scientific Title

The role of sirtuin in the pathogenesis of age-related ocular disease.

Scientific Title:Acronym

Sirtuin in the pathogenesis of age-related ocular disease.

Region

Japan


Condition

Condition

cataract, glaucoma, age related macula degeneration, diabetic retinopthy, retinal vein occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the role of Sirtuin in the pathogenesis of age-related ocular disease.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intraocular levels of sirtuins

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Operation and intraocular injection of drugs

Interventions/Control_2

No-treatment

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with age-related ocular disease.

Key exclusion criteria

Patients without agreement for this study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Mimura

Organization

Tokyo Women&#39;s Medical University Medical Center East

Division name

Ophthalmology

Zip code


Address

2-1-10 Nishiogu, Arakawa-ku, Tokyo, 116-8567 Japan

TEL

03-3810-1111

Email

mimuraop@dnh.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Mimura

Organization

Tokyo Women&#39;s Medical University Medical Center East

Division name

Ophthalmology

Zip code


Address

2-1-10 Nishiogu, Arakawa-ku, Tokyo, 116-8567 Japan

TEL

03-3810-1111

Homepage URL


Email

mimuraop@dnh.twmu.ac.jp


Sponsor or person

Institute

Tokyo Women&#39;s Medical University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Women&#39;s Medical University

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 10 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

2014 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 10 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

2014 Year 04 Month 10 Day

Last modified on

2016 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015976


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name