UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057639 |
|---|---|
| Receipt number | R000065857 |
| Scientific Title | An Observational Study on the Efficacy and Safety of Faricimab for Diabetic Macular Edema, Age-related Macular Degeneration, and Retinal Vein Occlusion |
| Date of disclosure of the study information | 2025/04/17 |
| Last modified on | 2025/10/23 11:01:36 |
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Basic information
Public title
An Observational Study of Faricimab Treatment for Diabetic Macular Edema, Age-related Macular Degeneration, and Retinal Vein Occlusion
Acronym
Faricimab Real-world Observational Study
Scientific Title
An Observational Study on the Efficacy and Safety of Faricimab for Diabetic Macular Edema, Age-related Macular Degeneration, and Retinal Vein Occlusion
Scientific Title:Acronym
FARICIMAB-RO (Observational)
Region
| Japan |
Condition
Condition
Diabetic Macular Edema, Age-related Macular Degeneration, and Macular Edema Secondary to Retinal Vein Occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to retrospectively evaluate the changes in visual acuity, central subfield thickness, resolution of retinal fluid, recurrence rate, and safety outcomes in patients with diabetic macular edema (DME), age-related macular degeneration (AMD), or retinal vein occlusion (RVO) treated with intravitreal faricimab. The study also aims to assess the association between optical coherence tomography (OCT)-based biomarkers and treatment outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Central Subfield Thickness (CST) from baseline to 24 months after the initiation of treatment
Key secondary outcomes
Change in best-corrected visual acuity (BCVA, logMAR)
Resolution rate of intraretinal fluid (IRF) and subretinal fluid (SRF), and time to resolution
Recurrence rate and time to recurrence of retinal fluid
Final injection interval of intravitreal faricimab
Total number of intravitreal faricimab injections
Changes in OCT biomarkers before and after treatment, including SRF, IRF, chronic cysts, HRF, DRILs, VMA/VMT, ERM, ELM disruption, EZ disruption, serous PED, SRHM, GA, and fibrotic scar
Associations between baseline biomarkers and treatment outcomes (CST change, BCVA change, recurrence)
Incidence of ocular and systemic adverse events
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria:
Diagnosed with diabetic macular edema (DME), age-related macular degeneration (AMD), or retinal vein occlusion (RVO)
Treated with intravitreal faricimab
Aged 18 years or older at the start of treatment
No restriction on gender
Key exclusion criteria
Patients who meet any of the following criteria:
Presence of other active ocular diseases (e.g., retinal detachment, uveitis)
Underwent other treatments such as laser therapy or surgery during the study period
Incomplete clinical records that preclude analysis of key endpoints
Pregnant or breastfeeding women
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama City University Hospital
Division name
Department of Ophthalmology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL
045-787-2683
mizunobu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama City University Hospital
Division name
Department of Ophthalmology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL
0457872683
Homepage URL
mizuki.yuk.xj@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
Research Ethics Committee, Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
Tel
0453707627
yokohama-cu@esct.bvits.com
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
横浜市立大学附属病院/ Yokohama City University Hospital
社会福祉法人 親善福祉協会 国際親善総合病院（診療録情報提供のみ）/ International Goodwill Hospital (Data provision only)
国家公務員共済組合連合会 横浜南共済病院（診療録情報提供のみ）/ Yokohama Minami Kyosai Hospital (Data provision only)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 17 | 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
150
Results
RVO-ME (3 m): 23 eyes; BCVA 0.40 to 0.22 logMAR (p=0.0025); CST 352 to 194 um (p<0.001); fluid-free 52%; no SAEs. DME (2 y): 16 eyes; CST 332 to 267 um (p=0.069); BCVA stable (0.49 to 0.55, p=0.208); fixed-dosing: >=12-wk 72.7%, >=16-wk 36.4%; no TRAEs. nAMD (1 y): 21 eyes; CST fell at 6/12 m with stable vision; >=12-wk 61.9%, >=16-wk 23.8%; no SAEs.
Results date posted
| 2025 | Year | 10 | Month | 23 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The release was delayed because the integrated report including the nAMD cohort is under journal peer review. To respect the peer-review process and avoid duplicate dissemination, we postponed posting on UMIN. Additional time was required for multi-center data cleaning and confirmation of follow-up.
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 29 | Day |
Baseline Characteristics
Three cohorts were included: RVO-ME (23 eyes), DME (16 eyes), and nAMD (21 eyes).
RVO-ME: baseline BCVA 0.40 logMAR; CST 352 um.
DME: baseline BCVA 0.49 logMAR; CST 332 um.
nAMD: mainly eyes with active exudation at baseline.
Each cohort included both treatment-naive and switch cases.
Participant flow
Participating sites: Department of Ophthalmology and Visual Science, Yokohama City University; Yokohama Minami Kyosai Hospital (Ophthalmology); International Goodwill Hospital (Ophthalmology).
Consecutive eyes treated with faricimab at these sites were screened.
Enrolled and analyzed: RVO-ME 23 eyes, DME 16 eyes, nAMD 21 eyes.
Exclusions: inadequate follow-up, poor image quality, or conditions preventing reliable foveal assessment.
Analysis sets: all treated eyes for safety; eyes with available data at predefined visits for effectiveness.
Assessment points: 3 months for RVO-ME, 24 months for DME, and 12 months for nAMD.
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted at Yokohama City University Hospital as the primary institution. International Goodwill Hospital and Yokohama Minami Kyosai Hospital participate by providing existing medical records only, without any new interventions or examinations. All data will be anonymized prior to analysis. The study findings are expected to be presented at academic conferences and submitted for publication in peer-reviewed journals.
Management information
Registered date
| 2025 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065857
