UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048394 |
|---|---|
| Receipt number | R000055163 |
| Scientific Title | Switching from existing anti-VEGF agents to ranibizumab BS in age-related macular degeneration |
| Date of disclosure of the study information | 2022/07/18 |
| Last modified on | 2022/08/04 21:33:54 |
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Basic information
Public title
Switching from existing anti-VEGF agents to ranibizumab BS in age-related macular degeneration
Acronym
Switching from existing anti-VEGF agents to ranibizumab BS in AMD
Scientific Title
Switching from existing anti-VEGF agents to ranibizumab BS in age-related macular degeneration
Scientific Title:Acronym
Switching from existing anti-VEGF agents to ranibizumab BS in AMD
Region
| Japan |
Condition
Condition
Age-Related Macular Degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to examine changes in the frequency of drug administration directly related to the patient treatment burden in AMD eyes that have been switched from existing anti-VEGF drugs to ranibizumab BS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interval/frequency of anti-VEGF agents during the follow-up 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with AMD who has been treated with existing anti-VEGF agents using the Treat and Extend (TAE) regimen for more than one year and who has decided to switch to ranibizumab BS at the patient's request.
Key exclusion criteria
Patients with unstable drug administration intervals with TAE regimen using existing anti-VEGF drugs, patients with other concomitant ocular diseases such as active uveitis and proliferative diabetic retinopathy, patients who have undergone previous vitrectomy or treatment with unknown details at other hospitals, and patients for whom anterior chamber fluid sampling by anterior chamber puncture is deemed unsafe.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya university hospital
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2275
h-kaneko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Takeuchi |
Organization
Nagoya University Hospital
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2275
Homepage URL
takeuchi.jun@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co.,Ltd.
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
Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2479
ethics@med.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
| 2022 | Year | 07 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 14 | 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
none
Management information
Registered date
| 2022 | Year | 07 | Month | 17 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055163
