UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055171 |
|---|---|
| Receipt number | R000062318 |
| Scientific Title | A Retrospective Observational Study Exploring Factors Influencing the Response to Faricimab in Exudative Age-related Macular Degeneration |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2025/02/06 18:19:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Retrospective Observational Study Exploring Factors Influencing the Response to Faricimab in Exudative Age-related Macular Degeneration
Acronym
The Effect of Faricimab on Exudative Age-related Macular Degeneration
Scientific Title
A Retrospective Observational Study Exploring Factors Influencing the Response to Faricimab in Exudative Age-related Macular Degeneration
Scientific Title:Acronym
The Effect of Faricimab on Exudative Age-related Macular Degeneration
Region
| Japan |
Condition
Condition
Exudative age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Currently, the first-line treatment for exudative age-related macular degeneration (AMD) involves intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs (ranibizumab, aflibercept, brolucizumab) or the anti-VEGF/angiopoietin-2 drug (faricimab). These intravitreal injections have been shown to improve visual acuity, and continued administration during the maintenance phase can sustain these improvements over the long term. However, regardless of the drug used, a certain proportion of patients exhibit suboptimal responses.
Faricimab, an anti-VEGF/angiopoietin-2 drug, not only suppresses exudation through its anti-VEGF action but also promotes pericyte coverage and vascular stabilization via its anti-angiopoietin-2 action, which is expected to allow for extended dosing intervals. Over a year has passed since its release, and several real-world clinical outcomes for exudative AMD treatment have been reported. The applicant has reported that, following three monthly injections of faricimab for exudative AMD, exudation resolved in 82% of patients, while 18% exhibited persistent exudation. This suggests that, similar to aflibercept, there are cases of resistance to faricimab. However, it remains unclear whether cases resistant to faricimab overlap with those resistant to aflibercept, and no clinical factors predicting response to faricimab have been identified. Currently, it is very challenging to predict treatment responsiveness to these drugs in advance.
This study aims to elucidate the differences in responsiveness to faricimab by focusing on various clinical parameters, including the morphology of macular neovascularization. Additionally, it seeks to clarify the criteria for selecting faricimab in clinical practice.
Basic objectives2
Others
Basic objectives -Others
Visual Outcomes Following Faricimab Induction Therapy
Elucidating the Clinical and Morphological Characteristics of Responders and Non-responders
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of responders and non-responders classified by the presence or absence of exudative changes after induction therapy with faricimab and by the dosing intervals at 48 weeks.
Key secondary outcomes
Visual Acuity Changes at 48 Weeks
Changes in Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (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 aged 50 years or older with exudative AMD who received faricimab injections at Kyorin University Hospital between May 2022 and the date of ethical review approval. The subjects will be consecutive cases that have been followed for more than one year.
Key exclusion criteria
Patients who refused to participate in this study will be excluded. Additionally, patients who could not obtain OCT and OCTA images at the start of faricimab administration and during treatment, as well as those with other eye diseases, will be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kataoka |
Organization
Kyorin University
Division name
Department of Ophthalmology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitakashi, Tokyo, Japan
TEL
0422-47-5511
keiko-kataoka@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kataoka |
Organization
Kyorin Univerisyt
Division name
Department of Ophthalmology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitakashi, Tokyo, Japan
TEL
0422-47-5511
Homepage URL
keiko-kataoka@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharma
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
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2, Shinkawa, Mitakashi, Tokyo, Japan
Tel
0422-47-5511
rec@ks.kyorin-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
| 2024 | Year | 08 | Month | 07 | 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
60
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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062318
