UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effectiveness against retinal vascular occlusion treated with retinal endovascular surgery using tissue plasminogen activator.
Title of the study (Brief title)	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	Chie Sotozono
Organization	Kyoto Prefectual Univercity of Medicine
Division name	Department of Ophthalmology
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	Yoichiro Shinkai
Organization	Kyoto Prefectual Univercity of Medicine
Division name	Department of Ophthalmology
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
Institute	Kyoto Prefectual Univercity of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028292