UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019771
Receipt number R000022834
Scientific Title Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema
Date of disclosure of the study information 2015/11/13
Last modified on 2017/09/19 16:58:15

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Basic information

Public title

Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema

Acronym

Ranibizumab and chorioretinal blood flow

Scientific Title

Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema

Scientific Title:Acronym

Ranibizumab and chorioretinal blood flow

Region

Japan


Condition

Condition

Retinal vein occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate treatment outcomes including BCVA, OCT-findings and chorioretinal hemodynamics by stratified analysis according to the first IVR treatment response on VA and CFT.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Population of visual improvemnt after the first intravitreal injection of Ranibizumab.

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

Medicine

Interventions/Control_1

Duration:12months
Quantity:Ramibizumab 0.5mg/injection

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

Patients with macular edema due to retinal vein occlusion who visit Tokyo women's medical university
Central foveal thickness over 250 micron.
Visual acuity over 0.1

Key exclusion criteria

Othe ocular pathology
Past history of brain and myocardial infarction.
Uncontrolled hypertention.
Anti-VEGF treatment for general diseases.
Laser, Anti-VEGF, intravitreal injection of steroid and vitrectomy for ocular pathology.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomohiro Iida

Organization

Tokyo women's Medical University

Division name

Department of Ophthalmology

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Email

iida@oph.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Kogure

Organization

Tokyo women's Medical University

Division name

Department of Ophthalmology

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Homepage URL


Email

kogure.akiko@twmu.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Tokyo women's Medical University

Institute

Department

Personal name



Funding Source

Organization

Novartis Pharmaceuticals Japan

Organization

Division

Category of Funding Organization

Profit organization

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

2015 Year 11 Month 13 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

2013 Year 11 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 15 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

2015 Year 11 Month 13 Day

Last modified on

2017 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022834


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name