UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042729 |
|---|---|
| Receipt number | R000048701 |
| Scientific Title | Safety and efficacy of switching from Aflibercept to Brolucizumab in patients with neovascular AMD |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2023/12/25 15:39:58 |
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Basic information
Public title
Safety and efficacy of switching from Aflibercept to Brolucizumab in patients with neovascular AMD
Acronym
Safety and efficacy of switching from Aflibercept to Brolucizumab in patients with neovascular AMD
Scientific Title
Safety and efficacy of switching from Aflibercept to Brolucizumab in patients with neovascular AMD
Scientific Title:Acronym
Safety and efficacy of switching from Aflibercept to Brolucizumab in patients with neovascular AMD
Region
| Japan |
Condition
Condition
Neovascular age-related macular degenereation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Age-related macular degeneration is a major cause of blindness in Japan, and the number of affected patients has been increasing. Neovascular age-related macular degeneration causes growth of abnormal vessels in choroid or retina and deteriorates the retina leading visual decline and central scotoma. To repress the activity of the neovascularization, intravitreal injection of anti-vascular endothelial growth factor agents needs to be done regularly in most cases. In particular, some cases need the injection every one or two months, and this burden for patients and medical insurance has been grown significantly. On this March, brolucizumab (trade name: Beovu) was approved by the authority as a new anti-vascular endothelial growth factor agent for neovascular age-related macular degeneration. As brolucizumab is a small molecular than other anti-vascular endothelial growth factor agent and can be delivered at high dose, it is expected to have long-term effect and may extend the injection period by switching from aflibercept. The purpose of this study is to investigate the possibility of extension of the injection period by switching the agent from aflibercept to brolucizumab and to establish best approach for neovascular age-related macular degeneration, consequently, to relive the burden for patients and medical insurance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of mean injection period after switching to brolucizumab.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Brolucizumab will be intravitreally injected to the eligible eyes with the same injection period of the previous agent, and efficacy and safety of the brolucizumab will be analyzed. The second injection of the brolucizumab will be injected with the interval of 4 weeks, then the third injection will be injected with the interval of 8weeks, and the following injection will be injected with the interval of previous injection plus 2 weeks unless the activity of neovascularization won't be detected. If the activity of neovascularization reemerges, the injection period will be shortened by 2 weeks until the activity of neovascularization cannot be detected. In case, the injection period needs to be less than 8weeks, switching the agents is considered failure. The failed eye will be excluded from this study and returned to the previous treatment.
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
The eyes with active neovascular age-related macular degeneration under treatment of the existing anti-vascular endothelial grow factor (aflibercept) within 10-week post-injection and need the additional injections within every 8 weeks.
Key exclusion criteria
Not applicable
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TAKAAKI |
| Middle name | |
| Last name | MATSUKI |
Organization
National Hospital Organization
Tokyo Medical Center
Division name
Ophthalmology
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
215-rinri@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | TAKAAKI |
| Middle name | |
| Last name | MATSUKI |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Ophthalmology
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
215-rinri@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Tokyo Medical Center
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
National Hospital Organization Tokyo Medical Center
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
Tel
03-3411-0111
215-rinri@mail.hosp.go.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
国立病院機構 東京医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 11 | 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
| 2020 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048701
