UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate the effect of ripasudil hydrochloride hydrate eye drops for retinal vein occlusion(RVO)
Title of the study (Brief title)	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	Tsuyoshi Otsuji
Organization	Kansai Medical University Medical Center
Division name	Ophthalmology
Address	10-15 Fumizonocho Moriguchi, Osaka
TEL	06-6992-1001
Email	otsuji@takii.kmu.ac.jp

Public contact
Name of contact person	Tsuyoshi Otsuji
Organization	Kansai Medical University Medical Center
Division name	Ophthalmology
Address	10-15 Fumizonocho Moriguchi, Osaka
TEL	06-6992-1001
Homepage URL
Email	otsuji@takii.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035417