UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intraretinal vessel treatment for central retinal vein occlusion
Title of the study (Brief title)	IVTEC
Region	Japan

Condition
Condition	Cetntral Retinal Artery and Vein Occlusion
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of intraretinal vascular surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Visual acuity (ETDRS charts), Retinal thickness
Key secondary outcomes

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Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	cannulation
Interventions/Control_2	bevacizumab
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Participants were eligible for inclusion in the study if the CRVO duration was 6 months or less, the best-corrected visual acuity (BCVA) was between 15-65 ETDRS letters, and the mean central subfoveal thickness was more than 300 micrometers as measured using OCT.
Key exclusion criteria	Key exclusion criteria included CRVO with neovascularization, any previous treatment for CRVO, intraocular surgery during the previous 3 months, vascular retinopathy arising from other causes, glaucoma with an advanced visual field defect or uncontrolled ocular hypertension (25 mmHg) despite full therapy, and myocardial infarction or stroke during the last 12 months. All the participants provided their written informed consent.
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuaki Kadonosono
Organization	Yokohama City University Medical Center
Division name	Depatment of Ophthalmology
Address	4-57, Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa
TEL	045-253-5372
Email	kado@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Kazuaki Kadonosono
Organization	Yokohama City University Medical Center
Division name	Department of Ophthalmology
Address	4-57 Urafune-cho, Minami-ku,Yokohama-shi, Kanagawa
TEL	045-261-5656
Homepage URL
Email	kado@med.yokohama-cu.ac.jp

Sponsor
Institute	Intraretinal vessel treatment for central retinal vein occlusion study team
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 03 Month 01 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2014 Year 07 Month 01 Day
Date of closure to data entry	2014 Year 08 Month 01 Day
Date trial data considered complete	2014 Year 09 Month 01 Day
Date analysis concluded	2014 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 15 Day
Last modified on	2016 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009360