UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052626 |
|---|---|
| Receipt number | R000059992 |
| Scientific Title | Five-Year Outcomes of Treat and Extend Regimen Using Intravitreal Aflibercept Injection for Treatment-Naive Age-Related Macular Degeneration |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2023/10/26 22:06:42 |
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Basic information
Public title
Five-Year Outcomes of Treat and Extend Regimen Using Intravitreal Aflibercept Injection for Treatment-Naive Age-Related Macular Degeneration
Acronym
Five-Year Outcomes of Treat and Extend Regimen Using Intravitreal Aflibercept Injection for Treatment-Naive Age-Related Macular Degeneration
Scientific Title
Five-Year Outcomes of Treat and Extend Regimen Using Intravitreal Aflibercept Injection for Treatment-Naive Age-Related Macular Degeneration
Scientific Title:Acronym
Five-Year Outcomes of Treat and Extend Regimen Using Intravitreal Aflibercept Injection for Treatment-Naive Age-Related Macular Degeneration
Region
| Japan |
Condition
Condition
Age-Related Macular Degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate long-term outcomes in eyes with neovascular age-related macular degeneration (AMD) treated with aflibercept according to a treat-and-extend (TAE) up to 5 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data including best-corrected visual acuity (BCVA), intervals of treatments, the presence of exudation, central retinal thickness (CRT), and central choroidal thickness (CCT) were analyzed.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients were included in the study if they had been continuously treated with intravitreal aflibercept injections using the TAE regimen for at least 1 years.
Key exclusion criteria
Patients who received treatment including anti-VEGF intravitreal injections prior to initiation of aflibercept intravitreal injections or who have diabetic retinopathy, myopic choroidal neovascularization, or other retinal diseases in addition to AMD
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Ota |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture, Japan
TEL
052-741-2111
hkaruu.otaa@gmail.com
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Ota |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture, Japan
TEL
052-741-2111
Homepage URL
hkaruu.otaa@gmail.com
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture, Japan
Tel
052-741-2111
hikaruu.otaa@gmail.com
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
| 2023 | Year | 10 | Month | 31 | 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
112
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational, consecutive case series conducted in the Ophthalmology Department of Nagoya University Hospital. This study was performed in accordance with the Helsinki Declaration, was approved by the institutional review board of Nagoya University Graduate School of Medicine.
Management information
Registered date
| 2023 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059992
