UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000682
Receipt number R000000747
Scientific Title Treatment of retinal vein occulusion
Date of disclosure of the study information 2007/04/18
Last modified on 2021/06/09 19:38:34

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Basic information

Public title

Treatment of retinal vein occulusion

Acronym

Treatment of RVO

Scientific Title

Treatment of retinal vein occulusion

Scientific Title:Acronym

Treatment of RVO

Region

Japan


Condition

Condition

retinal vein occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate treatment for retinal vein occlusion

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual acuity,retinal thickness

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

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Intravitreal injection of triamcinolone

Interventions/Control_2

vitrectomy

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Retinal vein occlusion patient who written informed consent was obtained .

Key exclusion criteria

Patients who did not agree with this study.
Patients who rised of intraocular pressure by using steroid eye drops.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hidetoshi
Middle name
Last name Yamashita

Organization

Yamagata University,School of Medicine

Division name

Department of Ophthalmology

Zip code

990-9585

Address

Iidanishi 2-2-2,yamagata city

TEL

0236285374

Email

nakano-ygt@umin.ac.jp


Public contact

Name of contact person

1st name Katuhiro
Middle name
Last name Nishi

Organization

Yamagata University,School of Medicine

Division name

Department of Ophthalmology

Zip code

990-9585

Address

Iidanishi 2-2-2, Yamagata

TEL

0236285374

Homepage URL


Email

ka-nishi_24.medical@sepia.ocn.ne.jp


Sponsor or person

Institute

Department of Ophthalmology,Yamagata University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology,Yamagata University, School of Medicine

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

the Ethical Review Committee of Yamagata University Faculty of Medicine

Address

Iida-nishi 2-2-2,Yamagata city

Tel

023-633-1122

Email

ikekenkyu@jm.kj.yamagata-u.ac.jp


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

2007 Year 04 Month 18 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Enrolling by invitation

Date of protocol fixation

2007 Year 02 Month 19 Day

Date of IRB

2007 Year 02 Month 19 Day

Anticipated trial start date

2007 Year 03 Month 01 Day

Last follow-up date

2026 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2007 Year 04 Month 17 Day

Last modified on

2021 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name