UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056994 |
|---|---|
| Receipt number | R000065106 |
| Scientific Title | Efficacy of switching from existing anti-vascular endothelial growth factor drugs to ranibizumab biosimilar in neovascular age-related macular degeneration |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/10 15:57:12 |
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Basic information
Public title
Efficacy of switching from existing anti-vascular endothelial growth factor drugs to ranibizumab biosimilar in neovascular age-related macular degeneration
Acronym
Efficacy of ranibizumab biosimilar in neovascular age-related macular degeneration
Scientific Title
Efficacy of switching from existing anti-vascular endothelial growth factor drugs to ranibizumab biosimilar in neovascular age-related macular degeneration
Scientific Title:Acronym
Efficacy of ranibizumab biosimilar in neovascular 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
This study examines the treatment burden, efficacy, and safety of ranibizumab biosimilar (BS) in nAMD eyes switched from existing anti-VEGF agents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity changes during the observation period
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
| 49 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which nAMD eyes, having remained stable for over a year with treatment using the Treat and Extend (TAE) method with existing anti-VEGF agents (ranibizumab, aflibercept), were switched to ranibizumab biosimilar (BS) based on patient preference.
Key exclusion criteria
Patients whose injection intervals were unstable despite treatment with the Treat and Extend (TAE) method using existing anti-VEGF agents, cases with concurrent ocular diseases such as active uveitis or proliferative diabetic retinopathy, cases with a history of vitrectomy or treatments performed at other institutions with insufficient details, and cases in which anterior chamber fluid sampling via anterior chamber paracentesis was deemed unsafe.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Nishiguchi |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-741-2111
nishiguchi.koji.f6@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Ota |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture, Japan
TEL
052-741-2111
Homepage URL
ota.hikaru.f9@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital, Department of Ophthalmology
Institute
Department
Personal name
Hikaru Ota
Funding Source
Organization
SENJU Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
iga-shinsa@adm.nagoya-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
| 2025 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
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
Main results already published
Date of protocol fixation
| 2022 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Observational Study
Management information
Registered date
| 2025 | Year | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065106
