UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038335 |
|---|---|
| Receipt number | R000043640 |
| Scientific Title | The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University. |
| Date of disclosure of the study information | 2019/10/21 |
| Last modified on | 2021/04/22 17:04:22 |
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Basic information
Public title
The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Acronym
The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Scientific Title
The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Scientific Title:Acronym
The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Region
| Japan |
Condition
Condition
age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the treatment of anti-vascular endothelial growth factor (VEGF) agents injection for age-related macular degeneration (AMD), patients are needed for prolonged repeated treatment for the recurrence exudation to maintenance of visual acuity, and physical, psychological and economic burden of patients become problem. The recurrence intervals of AMD are differ in individuals, so it is be considered that the retreatment intervals of anti-VEGF agents injection had better to be adjusted to provide the needed performance with minimum injections. So we considered that more individualized retreatment regimen could be these alleviate a burden on patients. In this study, we evaluated retrospectively the treatment effect and interval of intravitreal aflibercept injection preferentially for untreated AMD in Yamaguchi University Hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of visual acuity at 2nd year after starting treatment
Key secondary outcomes
The treatment interval of aflibercept at 2nd year after starting treatment
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
Untreated age-related macular degeneration patients started the treatment of aflibercept injection during study period
Key exclusion criteria
1) The patient who had a history of treatment using anti-VEGF agents, 2) The patient who entry to other intervention study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kimura |
Organization
Yamaguchi University graduate school of medicine
Division name
Department of Ophthalmology
Zip code
755-0032
Address
1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
TEL
0836-22-2278
k.kimura@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Wakuta |
Organization
Yamaguchi University graduate school of medicine
Division name
Department of Ophthalmology
Zip code
755-0032
Address
1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
TEL
0836-22-2278
Homepage URL
mwakut@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology Yamaguchi University graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology Yamaguchi University graduate school of medicine
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
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
Tel
0836-22-2428
me223@yamaguchi-u.ac.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
| 2019 | Year | 10 | Month | 21 | 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
73
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
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective observational study without intervention. Treatment naive exdative age-related macular degeneration patients using aflibercept injetion from 1st/Aug./2013 to 31th/Jul./2017 in Yamaguchi University Hospital.
extracted items; gender, birth year/month, diagnosis, the date of first treatment, used drug, adverse events, treatment history, current medical history, examination findings of the eye, visual acuity, intraocular pressure, the findings of fluorescein and indocyanine green angiography, optical coherence tomography, color fundus photograph
Management information
Registered date
| 2019 | Year | 10 | Month | 18 | Day |
Last modified on
| 2021 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043640
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