UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005339 |
|---|---|
| Receipt number | R000006343 |
| Scientific Title | Efficacy of kallidinogenase for clinically significant macular edema with diabetic retinopathy |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2021/01/14 13:17:59 |
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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
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
t-eiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Ophthalmology OF NAGASAKI UNIVERSITY HOSPITAL
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006343
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
