UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of plasminogen activator in ophthalmology
Title of the study (Brief title)	Treatment of t-PA in ophthalmology
Region	Japan

Condition
Condition	Submacular hemorrhage, Retinal vein occlusion, Fibrin formation due to postoperative inflammation
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of the treatment protocol using a tissue plasminogen activator in ophthalmology.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event
Key secondary outcomes	Visual acuity, Visual field, Retinal thickness, Intraocular pressure

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	Injecting tissue plasminogen activator(0.025mg/0.1ml)0.02-0.2ml into a subretinal cavity or a retinal vascular in vitreous surgery. Injecting tissue plasminogen activator(0.025mg/0.1ml)0.05-0.1ml into an anterior chamber or a intravitreal cavity with fibrin formation.
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	(1)Patients who have submacular hemorrhage, RVO, fibrin formation due to postoperative inflammation (2)Patients who were sufficient explanatation about using t-PA, and could get informed consent.
Key exclusion criteria	(1)Patients who are during lactation or pregnancy or expected pregnancy (2)Patients who have active eye/eyelid inflammation or disease or infection (3)Patients who have hemorrhagic diathesis (4)Patients who are judged to be inappropriate for this trial by the judgement of the doctor.
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuhisa Sugiyama
Organization	Kanazawa University
Division name	Department of Ophthalmology
Address	13-1, Takara-machi, Kanazawa, Ishikawa
TEL	0762652403
Email	ksugi@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Toshinori Masaki
Organization	Kanazawa University
Division name	Department of Ophthalmology
Address	13-1, Takara-machi, Kanazawa, Ishikawa
TEL	0762652403
Homepage URL
Email	tmasaki@med.kanazawa-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kanazawa University
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Kanazawa University
Organization
Division
Category of Funding Organization	Self funding
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 11 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 06 Day
Anticipated trial start date	2017 Year 11 Month 06 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	2017 Year 11 Month 06 Day
Last modified on	2018 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034085