UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research about intraocular injection of tissue plasminogen activator(cleactor)
Acronym	Clinical research about intraocular injection of tissue plasminogen activator(cleactor)
Scientific Title	Clinical research about intraocular injection of tissue plasminogen activator(cleactor)
Scientific Title:Acronym	Clinical research about intraocular injection of tissue plasminogen activator(cleactor)
Region	Japan

Condition
Condition	diabetes retinopathy,retina vein occlusion,macular degeneration,subretinal hemorrhage,macula edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of safety and efficacy about intraocular injection of tissue plasminogen activator(t-PA)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual acuity
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Object : The patient of diabetes retinopathy,retina vein occlusion,macular degeneration,subretinal hemorrhage,macula edema. Interventions : Intraocular injection of t-PA alone or other necessary treatment in parallel. Term : About 2weeks hospitalization. Dose : 40,000 IU(0.1ml) . Approach : Using a 27G needle intravitreal injection from 3.5mm rear from a limbus cornea.
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 who was enough explained and understand this study. The patient who agree this study by the free will and sign consent forms. The patient who was diagnosed t-PA is appropriate.
Key exclusion criteria	The patient who judged t-PA is inappropriate by principal investigator or member of a research project.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masayuki Horiguchi
Organization	Fujita Health University Hospital
Division name	Ophthalmology
Zip code
Address	1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL	81-0562-95-5177
Email	masayuki@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tadashi Mizuguchi
Organization	Fujita Health University Hospital
Division name	Ophthalmology
Zip code
Address	1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL	81-0562-95-5177
Homepage URL
Email	mizu@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	None
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
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 09 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	Completed
Date of protocol fixation	2017 Year 07 Month 04 Day
Date of IRB	2017 Year 06 Month 02 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2022 Year 01 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	2017 Year 07 Month 31 Day
Last modified on	2022 Year 02 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032550