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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023979
Receipt No. 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

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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
Email 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
Email hanakoi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute for Advancement of Clinical and Translational Science
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026911

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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