UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024593
Receipt number R000028292
Scientific Title Examination of the effectiveness against retinal vascular occlusion treated with retinal endovascular surgery using tissue plasminogen activator.
Date of disclosure of the study information 2017/01/01
Last modified on 2016/10/27 16:25:07

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Basic information

Public title

Examination of the effectiveness against retinal vascular occlusion treated with retinal endovascular surgery using tissue plasminogen activator.

Acronym

Examination of retinal endovascular surgery against retinal vascular occlusion.

Scientific Title

Examination of the effectiveness against retinal vascular occlusion treated with retinal endovascular surgery using tissue plasminogen activator.

Scientific Title:Acronym

Examination of retinal endovascular surgery against retinal vascular occlusion.

Region

Japan


Condition

Condition

retinal vein occlusion
retinal artery occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of the retinal endovascular therapy using tissue plasminogen activator against retinal vascular occlusion

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative week 1 : visual acuity, postoperative complication , Optical Coherence Tomography (OCT)
Postoperative week 4 : visual acuity, postoperative complication , OCT
Postoperative week 12 : visual acuity, postoperative complication , OCT
Postoperative week 24 : visual acuity, postoperative complication , OCT , fluorescein fundus angiography (FAG)

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

We inject tissue plasminogen activator (t-PA, a monteplase) 5000IU into a retinal vascular used in vitreous surgery.

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

The patient undergoing vitreous surgery and stay in hospital for about one week in our hospital.
The patient receives a sufficient explanation about vitreous surgery. The patient who we can get a patient's informed consent before conducting the treatment.

Key exclusion criteria

We take patient's past medical history. We exclude a patient with cerebrovascular disorders and patient with a history of cerebral infarction and blood disease.
And the case is judged to be at high risk to use t-PA for patients.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chie Sotozono

Organization

Kyoto Prefectual Univercity of Medicine

Division name

Department of Ophthalmology

Zip code


Address

465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto

TEL

075-251-5578

Email

csotozon@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoichiro Shinkai

Organization

Kyoto Prefectual Univercity of Medicine

Division name

Department of Ophthalmology

Zip code


Address

465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto

TEL

075-251-5578

Homepage URL


Email

yshinkai@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectual Univercity of Medicine

Institute

Department

Personal name



Funding Source

Organization

the cost from Kyoto Prefectual Univercity of Medicine, Department of Ophthalmology

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

2017 Year 01 Month 01 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

Preinitiation

Date of protocol fixation

2016 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 04 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

2016 Year 10 Month 27 Day

Last modified on

2016 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028292


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name