UMIN-CTR Clinical Trial

Public title

Quantitative and functional analyses of proteins in intraocular humor in patients with intraocular angiogenic diseases

Acronym

Quantitative and functional analyses of proteins in intraocular humor in patients with intraocular angiogenic diseases

Scientific Title

Quantitative and functional analyses of proteins in intraocular humor in patients with intraocular angiogenic diseases

Scientific Title:Acronym

Quantitative and functional analyses of proteins in intraocular humor in patients with intraocular angiogenic diseases

Region

Japan

Condition

diabetic retinopathy, bronchial retinal vein occulusion, age-related macular degenelation, uveitis, macular hole, epiretinal membrene, retinal detachement

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this research investigates the growth factor which extracts a sample from intraocular fluid(aqueous humor, vitreous body) or blood which undergoes an operation or not. Then we examine a kind and quantity or the property of a growth factor working in the eye. By investigating them, the cause and structure which a new blood vessel, a retinal edema or inflammation, etc. generates were found, and we think that it will be useful for a new cure in the future.

Basic objectives2

Others

Basic objectives -Others

The purpose of this research investigates the growth factor which extracts a sample from intraocular fluid(aqueous humor, vitreous body) or blood which undergoes an operation or not. Then we examine a kind and quantity or the property of a growth factor working in the eye. By investigating them, the cause and structure which a new blood vessel, a retinal edema or inflammation, etc. generates were found, and we think that it will be useful for a new cure in the future.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Association between clinical findings and protein levels or functions in intraocular humor

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criterion is the patient under hospitalization or going to hospital regularly in the Kyoto University hospital with retina diseases, such as diabetes retinopathy, retinal vein occlusion, uveitis, a macular hole, an epiretinal membrane, and retinal detachment.

Key exclusion criteria

We exclude the patients without a disease raised upword, and with the increase in a risk of following on extraction, such as anterior chamber disappearance, and an intraocular pressure fall. Furthermore, the patient to whom cognition and an intelligent function are falling, and the other patients who admit that doctor is unsuitable except.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Nagahisa Yoshimura

Organization

Kyouto-univercity

Division name

ophthalmology

Zip code

Address

54 shogoin-kawaharacyo, sakyo-ku, kyoto

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Kyouto-univercity

Division name

ophthalmology

Zip code

Address

TEL

Homepage URL

Email

tayo2525@kuhp.kyoto-u.ac.jp

Institute

kyoto-univercity

Institute

Department

Personal name

Organization

department of ophthalmology & visual science kyoto univercity graduate school of medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

12

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2011

Year

12

Month

16

Day

Date of IRB

Anticipated trial start date

2011

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The purpose of this research investigates the growth factor which extracts a sample from intraocular fluid(aqueous humor, vitreous body) or blood which undergoes an operation or not. Then we examine a kind and quantity or the property of a growth factor working in the eye. By investigating them, the cause and structure which a new blood vessel, a retinal edema or inflammation, etc. generates were found, and we think that it will be useful for a new cure in the future.

Registered date

2011

Year

12

Month

16

Day

Last modified on

2011

Year

12

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008152