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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012793
Receipt No. R000014945
Scientific Title Studies on the predictive factors of treatment outcome after intravitreal injection of Lucentis (ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO)
Date of disclosure of the study information 2014/01/10
Last modified on 2018/05/27

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Basic information
Public title Studies on the predictive factors of treatment outcome after intravitreal injection of Lucentis (ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO)
Acronym Effect of ranibizumab in eyes with macular edema associated with CRVO
Scientific Title Studies on the predictive factors of treatment outcome after intravitreal injection of Lucentis (ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO)
Scientific Title:Acronym Effect of ranibizumab in eyes with macular edema associated with CRVO
Region
Japan

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

Objectives
Narrative objectives1 To study predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and after the treatment. Predictive factors of treatment outcome are statistically analyzed.
Key secondary outcomes

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, aqueous VEGF concentration, and new flicker electroretinogram (ERG) using skin electrodes
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 Macular edema secondary to CRVO, Central macular thickness > 300 um, Duration after the onset < 12 months
Key exclusion criteria Any history of previous treatments for CRVO
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Hospital
Division name Ophthalmology
Zip code
Address 2-174 Edobashi, Tsu, Mie, Japan
TEL 059-231-5027
Email Mineo@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Hospital
Division name Ophthalmology
Zip code
Address 2-174 Edobashi, Tsu, Mie, Japan
TEL 059-231-5027
Homepage URL
Email Mineo@clin.medic.mie-u.ac.jp

Sponsor
Institute Ophthalmology, Mie University Hospital
Institute
Department

Funding Source
Organization Novartis Pharma Co.
Organization
Division
Category of Funding Organization Profit organization
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 YES
Study ID_1 2638
Org. issuing International ID_1 Mie University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 三重大学医学部附属病院(三重県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 10 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 Completed
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
2016 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 08 Day
Last modified on
2018 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014945

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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