UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050137 |
|---|---|
| Receipt number | R000057119 |
| Scientific Title | One-year outcomes of switching to brolucizumab in nAMD refractory to aflibercept |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2026/01/28 15:34:54 |
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Basic information
Public title
Efficacy of brolucizumab for age-related macular degeneration
Acronym
Efficacy of brolucizumab
Scientific Title
One-year outcomes of switching to brolucizumab in nAMD refractory to aflibercept
Scientific Title:Acronym
Efficacy of switching to brolucizumab for wet age-related macular degeneration
Region
| Japan |
Condition
Condition
neovascular age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify the efficacy of switching to brolucizumab in nAMD refractory to aflibercept.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dry macula rate
Key secondary outcomes
The subtype of AMD, best corrected visual acuity, retinal thickness, choroidal thickness, number of treatments, treatment interval, age, sex, medical history (hypertension, diabetes, cerebral infarction, myocardial infarction), smoking history, complications (systemic: cerebral infarction,
myocardial infarction, topical: intraocular inflammation, endophthalmitis, rhegmatogenous retinal detachment, cataract)
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
nAMD patients refractory to aflibercept
Key exclusion criteria
Patients with CNV as a result of high myopia, angioid streaks, hereditary disorders, or uveitis were excluded.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kamao |
Organization
Kawasaki Medical School
Division name
Department of ophthalmology
Zip code
701-0114
Address
577 Matsushima Kurashiki, Okayama
TEL
0864621111
hironeri@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kamao |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology
Zip code
701-0114
Address
577 Matsushima Kurashiki, Okayama
TEL
0864621111
Homepage URL
hironeri@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kawasaki Medical School
Address
577 Matsushima Kurashiki, Okayama
Tel
0864621111
hironeri@med.kawasaki-m.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
| 2023 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1155/2024/3673930
Number of participants that the trial has enrolled
52
Results
One year after switching, BCVA changed from 0.28 to 0.19 in the loading group and from 0.25 to 0.23 in the nonloading group. Both the loading and nonloading groups achieved 69% dry macula. The number of injections received was significantly higher in the loading group.
Results date posted
| 2026 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with Aflibercept-Resistant nAMD
Participant flow
observation study
Adverse events
none
Outcome measures
Plan to share IPD
Best-corrected visual acuity, central retinal thickness at the fovea, subfoveal choroidal thickness, number of injections and last injection interval, and retinal exudate status on optical coherence tomography.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 01 | Month | 25 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057119
