UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057804 |
|---|---|
| Receipt number | R000066063 |
| Scientific Title | Exploring Patient and Treatment Factors Affecting Real-World Long-Term Visual Outcomes of Faricimab Proactive Therapy in Neovascular Age-Related Macular Degeneration |
| Date of disclosure of the study information | 2025/05/08 |
| Last modified on | 2025/05/08 18:30:22 |
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Basic information
Public title
Analysis of Faricimab Treatment Outcomes for Age-Related Macular Degeneration
Acronym
Faricimab 2-year results analysis
Scientific Title
Exploring Patient and Treatment Factors Affecting Real-World Long-Term Visual Outcomes of Faricimab Proactive Therapy in Neovascular Age-Related Macular Degeneration
Scientific Title:Acronym
Outcome of faricimab proactive treatment for neovascular age-related macular degeneration
Region
| Japan |
Condition
Condition
neovascular age-related macular degeneration (nAMD)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the real-world outcomes of two types of proactive treatment with faricimab (fixed regimen and TAE (treat and extend regimen)), focusing on the second year of treatment, retrospectively, the study aims to realize personalized medicine in which the optimal treatment regimen is established for each patient. The study of how to achieve the maximum effect with the least number of treatments may lead to a reduction in the burden on patients and hospitals, and thus to a decrease in medical costs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in visual acuity after 2 years of treatment
Key secondary outcomes
1. Retinal thickness and exudative changes during the course of treatment
2. Factors associated with the development of fibrotic scarring during treatment
3. Treatment outcome in subtypes such as PCV and pachychoroid
4. Visual course, number of treatments, and dosing interval
5. Search for prognostic factors (retinal imaging biomarkers such as OCT and OCTA)
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 over 50 years of age with neovascular age-related macular degeneration who have been followed for 2 years.
Key exclusion criteria
Patients who have received any previous treatment for neovascular age-related macular degeneration, patients with other retinal diseases, and patients with high myopia
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Hata |
Organization
Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name
ophthalmology
Zip code
606-8501
Address
Yoshidakonoecho,Sakyo-ku,Kyoto
TEL
075-751-3727
trj74h6@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Hata |
Organization
Kyoto University Hospital
Division name
Kyoto University Hospital Clinical Research Consultation Desk
Zip code
606-8507
Address
54 Shogoin-Kawaharacho,Sakyo-ku
TEL
075-751-4748
Homepage URL
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co.
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-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 | 05 | Month | 08 | 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
105
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
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | 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
Research Methods
(1) Design
Backward-looking cohort study
2) Method
Patients were treated with farisimab 6.0 mg intravitreal injection three times a month starting with the first dose, followed by fixed dosing intervals of either every 8 weeks, every 12 weeks, or every 16 weeks for 1 year (up to 14 months) based on disease activity assessment at 16 and 20 weeks, and then fixed dosing or treatment with treat and extend. Extend treatment. The study will be conducted retrospectively from medical records, with data obtained from visits up to 26 months after the start of treatment.
Management information
Registered date
| 2025 | Year | 05 | Month | 08 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066063
