UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031419
Receipt number R000035880
Scientific Title Quantitative analysis of retinal microvasculature in macular disease using optical coherence tomography (OCT)
Date of disclosure of the study information 2018/02/23
Last modified on 2018/02/22 16:33:45

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Basic information

Public title

Quantitative analysis of retinal microvasculature in macular disease using optical coherence tomography (OCT)

Acronym

Evaluation of macular disease by OCT angiography

Scientific Title

Quantitative analysis of retinal microvasculature in macular disease using optical coherence tomography (OCT)

Scientific Title:Acronym

Evaluation of macular disease by OCT angiography

Region

Japan


Condition

Condition

macular disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of retinal circulation of macular diseases by OCT angiography

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate retinal circulation of macular diseases by OCT angiography

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intravitreal vascular endothelial growth factor (VEGF) inhibitor injection

Interventions/Control_2

Retinal laser photocoagulation

Interventions/Control_3

Vitrectomy

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

macular desease

Key exclusion criteria

Dense cataract

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Mizota

Organization

Teikyo University

Division name

School of Medicine, Department of Ophthalmology

Zip code


Address

2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan

TEL

03-3964-1211

Email

mimurat@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Mimura

Organization

Teikyo University

Division name

School of Medicine, Department of Ophthalmology

Zip code


Address

2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan

TEL

03-3964-1211

Homepage URL


Email

mimurat@med.teikyo-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology,
Teikyo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

帝京大学医学部付属病院眼科学講座
埼玉医科大学病院眼科


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 23 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

2018 Year 02 Month 22 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 22 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

2018 Year 02 Month 22 Day

Last modified on

2018 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035880


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name