UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013236
Receipt number R000015446
Scientific Title changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion
Date of disclosure of the study information 2014/02/24
Last modified on 2016/08/29 09:35:01

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Basic information

Public title

changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion

Acronym

changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion

Scientific Title

changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion

Scientific Title:Acronym

changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion

Region

Japan


Condition

Condition

retinal vein occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy of treatment with intravitreal anti-VEGF injection by measuring ocular blood flow and vascular endothelial factors in patients with macular edema of retinal vein occlusion.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Before and one month, three months after the treatment

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

Maneuver

Interventions/Control_1

intravitreal injection and blood sampling

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

macular edema with retinal vein occlusion which have never been treated.

Key exclusion criteria

macular edema with retinal vein occlusion which have ever been treated.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teruyo Kida

Organization

Osaka Medical College

Division name

Ophthalmology

Zip code


Address

2-7 Daigaku-machi, Takatsuki, Osaka 569-8686

TEL

072-683-1221

Email

kida_teruyo@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Teruyo Kida

Organization

Osaka Medical College

Division name

Outpatients clinic of Ophthalmology

Zip code


Address

2-7 Daigaku-machi, Takatsuki, Osaka 569-8686

TEL

072-683-1221

Homepage URL


Email

kida_teruyo@yahoo.co.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Osaka Medical College

Organization

Division

Category of Funding Organization

Other

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 02 Month 24 Day


Related information

URL releasing protocol

http://www.ncbi.nlm.nih.gov/pubmed/27559424

Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/27559424

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

Completed

Date of protocol fixation

2012 Year 10 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 02 Month 24 Day

Last modified on

2016 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015446


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name