UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031064 |
|---|---|
| Receipt number | R000035417 |
| Scientific Title | To investigate the effect of ripasudil hydrochloride hydrate eye drops for retinal vein occlusion(RVO) |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/01/30 17:48:43 |
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Basic information
Public title
To investigate the effect of ripasudil hydrochloride hydrate eye drops for retinal vein occlusion(RVO)
Acronym
The effect of ripasudil eye drops for RVO
Scientific Title
To investigate the effect of ripasudil hydrochloride hydrate eye drops for retinal vein occlusion(RVO)
Scientific Title:Acronym
The effect of ripasudil eye drops for RVO
Region
| Japan |
Condition
Condition
Retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among patients with both retinal vein occlusion and glaucoma, those who do not achieve complete regression of macula edema with anti-VEGF drugs or who need frequent injection of anti-VEGF drugs are enrolled in this study. We consider if the patients achieve complete regression of macula edema or need less injection of anti-VEGF drugs using ripasudil hydrochloride hydrate eye drops which is one of the ROCK inhibitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in central retinal thickness measured by optical coherence tomography before and 12 after the treatment
Key secondary outcomes
The frequency of intravitreal injection of anti-VEGF drugs
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
Administration of ripasudil eye drops twice a day for 12 months.
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
Patients who have early glaucoma or ocular hypertension
Patients who do not have complete regression of macula edema with intravitreal injection of anti-VEGF drugs, or who need frequent injection of drugs to maintain the condition of complete disappearance of edema
Patients aged 20 years and older at the time of informed consent
Patients who gave written consent to study participation by free documentation and verbally enough explanation
Key exclusion criteria
Patients with other ocular disorders
Patients with a bad control of intra ocular pressure
Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Otsuji |
Organization
Kansai Medical University Medical Center
Division name
Ophthalmology
Zip code
Address
10-15 Fumizonocho Moriguchi, Osaka
TEL
06-6992-1001
otsuji@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Otsuji |
Organization
Kansai Medical University Medical Center
Division name
Ophthalmology
Zip code
Address
10-15 Fumizonocho Moriguchi, Osaka
TEL
06-6992-1001
Homepage URL
otsuji@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
| 2018 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 30 | Day |
Last modified on
| 2018 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035417
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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