UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of kallidinogenase for clinically significant macular edema with diabetic retinopathy
Acronym	Efficacy of kallidinogenase for CSME
Scientific Title	Efficacy of kallidinogenase for clinically significant macular edema with diabetic retinopathy
Scientific Title:Acronym	Efficacy of kallidinogenase for CSME
Region	Japan

Condition
Condition	Diabetic retinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect on the central macular thickness, visual acuity, blood flow of the ocular fundus, and the thickness of the choroid in the use of kallidinogenase for CSME.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We examine the effect on the central macular thickness, visual acuity, blood flow of the ocular fundus, and the thickness of the choroid for 3 months, and evaluate the recurrence of edema after 3months.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Kallidinogenase(+) 20 cases
Interventions/Control_2	Kallidinogenase(-) 20 cases
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	Patient whose age is 20 years old or more when agreement is acquired. Patient who obtained agreement after enough explanation when participating in this study is received.
Key exclusion criteria	Patient with freshness bleeding immediately after erebral hemorrhage. Patient who are allergic to kallidinogenase. Patient with poor control of blood sugar level, in brief HbA1c is above 10%. Patient with renal failure, in brief Cr is above 3mg/dl. Patient who is judged inappropriate for study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name TAKASHI Middle name Last name KITAOKA
Organization	Graduate School of Biomedical Sciences,Nagasaki University.
Division name	Department of Ophthalmology and Visual Sciences
Zip code	8528501
Address	1-7-1 Sakamoto Nagasaki 852-8501, JAPAN
TEL	095-819-7345
Email	tkitaoka@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name EIKO Middle name Last name TSUIKI
Organization	NAGASAKI UNIVERSITY HOSPITAL
Division name	Ophthalmology
Zip code	8528501
Address	1-7-1 Sakamoto, NAGASAKI
TEL	0958197345
Homepage URL
Email	t-eiko@nagasaki-u.ac.jp

Sponsor
Institute	Ophthalmology OF NAGASAKI UNIVERSITY HOSPITAL
Institute
Department

Funding Source
Organization	none
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	Nagasaki University Hospital
Address	1-7-1 Sakamoto Nagasaki Japan
Tel	0958197200
Email	t-eiko@nagasaki-u.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	長崎大学病院（長崎県）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/30275681/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/30275681/
Number of participants that the trial has enrolled	17
Results	BCVA at 6 months after treatment significantly improved in treated group (P<0.05).MBR at the disc and the macula at 6 months after treatment significantly decreased to 84.8% and 86.2%, respectively, in untreated group (P<0.05), though it remained unchanged at 98.7% and 99.7% in treated group.
Results date posted	2021 Year 01 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	All patients were given posterior sub-Tenon triamcinolone acetonide (STTA) injection and focal laser treatment session for DME.
Participant flow	prospective, open-labeled, randomized study
Adverse events	none
Outcome measures	best-corrected visual acuity (BCVA), central retinal thickness (CRT), subfoveal choroidal thickness (SCT), and chorioretinal blood flow level
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 25 Day
Date of IRB	2011 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2013 Year 10 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	2011 Year 03 Month 29 Day
Last modified on	2021 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006343