UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048108 |
|---|---|
| Receipt number | R000054830 |
| Scientific Title | Efficacy of Aflibercept for macular edema |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2023/06/21 21:57:56 |
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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
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
newyear98mt@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
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
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054830
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
