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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007958
Receipt No. R000009360
Scientific Title Intraretinal vessel treatment for central retinal vein occlusion
Date of disclosure of the study information 2012/05/15
Last modified on 2016/07/04

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Basic information
Public title Intraretinal vessel treatment for central retinal vein occlusion
Acronym IVTEC
Scientific Title Intraretinal vessel treatment for central retinal vein occlusion
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Kazuaki Kadonosono
Organization Yokohama City University Medical Center
Division name Depatment of Ophthalmology
Zip code
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
1st name
Middle name
Last name Kazuaki Kadonosono
Organization Yokohama City University Medical Center
Division name Department of Ophthalmology
Zip code
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

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)

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 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

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 Enrolling by invitation
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
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

Other
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

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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