UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013974
Receipt number R000011791
Scientific Title The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases.
Date of disclosure of the study information 2014/05/19
Last modified on 2019/05/24 15:53:30

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Basic information

Public title

The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases.

Acronym

The effcet of intra-vitreal bevacizumab.

Scientific Title

The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases.

Scientific Title:Acronym

The effcet of intra-vitreal bevacizumab.

Region

Japan


Condition

Condition

choroidal neovascularization, retinal vein occlusion, diabetic retinopathy, diabetic maculopathy, neovascular glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of the intravitreal bevacizumab for vascular endothelial factor-related intraocular disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Varidation on the visula acuity at 1, 3, 6, 12 months after intravitreal injection

Key secondary outcomes

Examination of macular forrmation and thickness by optical coherence tomography


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

Intravitreal 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 at Matsumoto Dental University with choroidal neovasucularization, retinal vein occlusion, diabetic retionopathy, uveitis, and neovascular glaucoma.

Key exclusion criteria

Patietns with uncontroled hypertension or with systemic risk factors of cerebral infarction or cardial infarction.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kouichi
Middle name
Last name Ohta

Organization

Matsumoto Dental Univeristy

Division name

Ophthalmology

Zip code

399-0781

Address

1780 Gobara, Hiooka, Shiojiri

TEL

0263-51-2360

Email

ohta@p.mdu.ac.jp


Public contact

Name of contact person

1st name Kouichi
Middle name
Last name Ohta

Organization

Matsumoto Dental University

Division name

Ophthalmology

Zip code

399-0781

Address

1780 Gobara, Hirooka, Shiojiri

TEL

0263-51-2360

Homepage URL


Email

ohta@po.mdu.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Matsumoto Dental University

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology,
Matsumoto Dental University

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

Matsumoto Dental University

Address

1780 Gobara, Hirooka, Shiojiri

Tel

0263-51-2188

Email

info_kakenhi@po.mdu.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

松本歯科大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 19 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

3

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

Terminated

Date of protocol fixation

2013 Year 03 Month 25 Day

Date of IRB

2013 Year 03 Month 31 Day

Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2019 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

2014 Year 05 Month 16 Day

Last modified on

2019 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011791


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name