UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023979 |
|---|---|
| Receipt number | R000026911 |
| Scientific Title | Phase 1/2 clinical trial to evaluate the safety and efficacy of daily intravitreal injections of KUS121 for three days in patients with non-arteritic central retinal artery occlusion |
| Date of disclosure of the study information | 2016/09/15 |
| Last modified on | 2018/03/13 10:28:39 |
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Basic information
Public title
Phase 1/2 clinical trial to evaluate the safety and efficacy of daily intravitreal injections of KUS121 for three days in patients with non-arteritic central retinal artery occlusion
Acronym
Phase 1/2 clinical trial of intravitreal injections of KUS121 in patients with central retinal artery occlusion
Scientific Title
Phase 1/2 clinical trial to evaluate the safety and efficacy of daily intravitreal injections of KUS121 for three days in patients with non-arteritic central retinal artery occlusion
Scientific Title:Acronym
Phase 1/2 clinical trial of intravitreal injections of KUS121 in patients with central retinal artery occlusion
Region
| Japan |
Condition
Condition
non-arteritic central retinal artery occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
KUS121, one of inhibitor of VCP (valosin-containing protein) ATPase has a protective effect on retinal cells in vitro and in animal models for ocular diseases. In this clinical trial, we investigate safety and eficacy of intravitreal injection of KUS121 on CRAO patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety: adverse events and side effects
Key secondary outcomes
adverse events related to the procedure of intravitreal injection
pharmacokinetics
visual acuity
visula field
Sensitivity of the retina
electroretinography
retinal thickness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
daily intravitreal injections KUS121 25 microgram for 3 days
daily intravitreal injections KUS121 50 microgram for 3 days
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) Age >= 20 years
2) Non-arteritic central retinal artery occlusion (CRAO)
3) Best-corrected visual acuity (BCVA) <= 0.1 and better than hand motion
4) Laboratory data obtained prior to enrollment meeting the following criteria:
Hemoglobin >= 10 g/dL
WBC count >= 2,000 /uL
Platelet count >= 100000 /uL
AST <= 50 IU/L
ALT <= 50 IU/L
Total bilirubin <= 1.5 mg/dL
Creatinine <= 1.5 mg/dL
5) Both men and women reporting the possibility of pregnancy were required to agree to be on contraception from the first injection until 4 weeks after the last injection.
6) Written informed consent of the patient
Key exclusion criteria
1) Patients who reported one or more of the following conditions: severe complications from cardiac, hepatic, or renal disease; poorly controlled diabetes mellitus
2) Eyes with the following conditions:
Acute ocular or periocular infection
Uncontrolled intra ocular pressure despite medication
Retinal venous occlusion
Abnormality in the macula
Opacity in the lens or the vitreous such that the fundus is not visible
3) Contralateral eye: BCVA <= 0.1, or visual field loss >= 1/2 of isopter I4e
4) Bilateral onset of CRAO
5) Systemic use of immunosuppressant or steroid medications
6) Participation in other studies during the period 16 weeks prior
7) Possibility or history of hypersensitivity reaction to fluorescein.
8) Inability to understand consent requirements, or unwillingness or inability to participate in all of the follow-up examinations
9) Decision by the principal investigator or the physician in charge that patient was unsuitable for participation in the present study
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hanako Ikeda |
Organization
Kyoto University Hospital
Division name
Institute for Advancement of Clinical and Translational Science
Zip code
Address
Shogoin-kawaharacho 54, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3248
hanakoi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hanako Ikeda |
Organization
Kyoto University Hospital
Division name
Institute for Advancement of Clinical and Translational Science
Zip code
Address
Shogoin-kawaharacho 54, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3248
Homepage URL
hanakoi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute for Advancement of Clinical and Translational Science
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kyoto Drug Discovery & Development Co., Ltd.
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学 医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 15 | 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
| 2016 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 08 | Day |
Last modified on
| 2018 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026911
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