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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048108
Receipt No. R000054830
Scientific Title Efficacy of Aflibercept for macular edema
Date of disclosure of the study information 2022/06/20
Last modified on 2022/06/20

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Basic information
Public title Efficacy of Aflibercept for macular edema in our hospital
Acronym Efficacy of Aflibercept for macular edema
Scientific Title Efficacy of Aflibercept for macular edema
Scientific Title:Acronym Efficacy of Aflibercept for macular edema
Region
Japan

Condition
Condition diabetic macular edema, retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 More than 5 years have passed since vitreous administration of anti-VEGF agents such as Aflibercept has become the gold-standard treatment, and the efficacy and results of use at this hospital should be grasped and used for future treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Central retinal thickness and best corrected visual acuity one month after the 3rd to 12th vitreal injection of Aflibercept
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who go to the outpatient department of ophthalmology at Chiba University Hospital
(2) Patients who received intra-vitreal injections of Aflibercept from January 2018 to December 2020
(3) Patients with diabetic macular edema or macular edema with retinal branch obstruction
(4) Patients who received intra-vitrealinjections of Aflibercept 3 times or more
Key exclusion criteria Patients who have not been followed up for more than 1 year
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Tatsumi
Organization Chiba University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Science
Zip code 260-8670
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 0432262124
Email newyear98mt@yahoo.co.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Tatsumi
Organization Chiba University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Science
Zip code 260-8670
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 0432262124
Homepage URL
Email newyear98mt@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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 Chiba University Graduate School of Medicine
Address 1-8-1, Inohana, Chuo-ku, Chiba
Tel 0432262124
Email inohana-rinri@chiba-u.jp

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
2022 Year 06 Month 20 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 300
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Currently, the data is being analyzed.
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 No longer recruiting
Date of protocol fixation
2020 Year 12 Month 13 Day
Date of IRB
2021 Year 01 Month 21 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is an observational study and analyzes the effect of treatment from medical records during the period.

Management information
Registered date
2022 Year 06 Month 20 Day
Last modified on
2022 Year 06 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054830

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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