UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007958 |
|---|---|
| Receipt number | 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 12:59:49 |
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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
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
kado@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Intraretinal vessel treatment for central retinal vein occlusion study team
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009360
