UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011310
Receipt No. R000013255
Scientific Title Correlation between macular edema and retinal sensitivity before and after anti-VEGF therapy for retinal vein occlusion
Date of disclosure of the study information 2013/07/30
Last modified on 2015/07/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Correlation between macular edema and retinal sensitivity before and after anti-VEGF therapy for retinal vein occlusion
Acronym Macular edema volume and visual sensitivity for retinal vein occlusion
Scientific Title Correlation between macular edema and retinal sensitivity before and after anti-VEGF therapy for retinal vein occlusion
Scientific Title:Acronym Macular edema volume and visual sensitivity for retinal vein occlusion
Region
Japan

Condition
Condition Retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate correlation between macular edema volume examined by F-10 and swept source OCT, and the retinal sensitivity examined by maia, before and after anti-VEGF drug intravitreal injection for macular edema due to retinal vein occlusion (CRVO).
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes macular edema volume
retinal sensitivity
Key secondary outcomes visual acuity

Base
Study type

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 bevacizumav
6 month
1.25mg (0.05ml)
1 and over (pro re nata)
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
40 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Case of macular edema due to retinal vein occlusion indicated for tratment of intravitreal bevacizumab
Key exclusion criteria case without retinal disease except retinal vein occlusion
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Daisuke Nagasato
Organization Tsukazaki hospital
Division name Ophthalmology
Zip code
Address 68-1 Aboshikuwaku Himeji Hyogo Japan
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Tsukazaki hospital
Division name Ophthalmology
Zip code
Address
TEL 0792-98-8555
Homepage URL
Email

Sponsor
Institute Tsukazaki hospital
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 30 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 Open public recruiting
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 06 Month 30 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 29 Day
Last modified on
2015 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013255

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.