UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015162
Receipt number R000017632
Scientific Title Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Date of disclosure of the study information 2014/09/16
Last modified on 2020/05/27 14:30:08

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Basic information

Public title

Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion

Acronym

Efficacy of intravitreal injection of aflibercept for retinal vein occlusion

Scientific Title

Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion

Scientific Title:Acronym

Efficacy of intravitreal injection of aflibercept for retinal vein occlusion

Region

Japan


Condition

Condition

retinal vein occulusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion

Basic objectives2

Others

Basic objectives -Others

Analysis of the association between the pathology and the factor of aqueous humor in eyes with retinal vein occlusion

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Analysis of the factor concerning the variation of best-corrected visual acuity 1 year after the first intravitreal injection

Key secondary outcomes

Analysis of the factor concerning the variation of best-corrected visual acuity and the regression of macular edema 2 year after the first intravitreal injection


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

interavitreal injection of 2.0mg of aflibercept

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with visual impairments due to macular edema associated with retinal vein oclusion

Key exclusion criteria

Patients with difficulty in intravitreal injection and examination because of mental retardation or dementia

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsujikawa Akitaka

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Ophthalmology and Visual Sciences

Zip code


Address

54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

TEL

075-751-3248

Email

tujikawa@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuki Muraoka

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Ophthalmology and Visual Sciences

Zip code


Address

54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

TEL

075-751-3248

Homepage URL


Email

muraoka@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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 09 Month 16 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

2014 Year 09 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 08 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

2014 Year 09 Month 15 Day

Last modified on

2020 Year 05 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017632


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name