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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015162
Receipt No. R000017632
Scientific Title Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Date of disclosure of the study information 2014/09/16
Last modified on 2018/09/18

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Basic information
Public title Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Acronym Efficacy of intravitreal injection of aflibercept for retinal vein occlusion
Scientific Title Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Scientific Title:Acronym Efficacy of intravitreal injection of aflibercept for retinal vein occlusion
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Basic objectives2 Others
Basic objectives -Others Analysis of the association between the pathology and the factor of aqueous humor in eyes with retinal vein occlusion
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Analysis of the factor concerning the variation of best-corrected visual acuity 1 year after the first intravitreal injection
Key secondary outcomes Analysis of the factor concerning the variation of best-corrected visual acuity and the regression of macular edema 2 year after the first intravitreal injection

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 interavitreal injection of 2.0mg of aflibercept
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

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 Patients with visual impairments due to macular edema associated with retinal vein oclusion
Key exclusion criteria Patients with difficulty in intravitreal injection and examination because of mental retardation or dementia
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsujikawa Akitaka
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address 54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3248
Email tujikawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Muraoka
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address 54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3248
Homepage URL
Email muraoka@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine
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 none
Organization
Division
Category of Funding Organization Other
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
2014 Year 09 Month 16 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
2014 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 15 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017632


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