UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057118 |
|---|---|
| Receipt number | R000065281 |
| Scientific Title | Study of Visual Function and Vision-Related Quality of Life Before and After Vitreous Injection of Faricimab in Retinal Vein Occlusion |
| Date of disclosure of the study information | 2025/02/26 |
| Last modified on | 2025/09/15 14:15:11 |
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Basic information
Public title
Study of Visual Function and Vision-Related Quality of Life Before and After Vitreous Injection of Faricimab in Retinal Vein Occlusion
Acronym
Study of Visual Function and Vision-Related QOL Before and After Vitreous Injection of Faricimab in RVO
Scientific Title
Study of Visual Function and Vision-Related Quality of Life Before and After Vitreous Injection of Faricimab in Retinal Vein Occlusion
Scientific Title:Acronym
Study of Visual Function and Vision-Related QOL Before and After Vitreous Injection of Faricimab in RVO
Region
| Japan |
Condition
Condition
Retinal Vein Occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate changes over time in subjective visual function and vison-related quality of life before and after treatment in patients treated with injection of faricimab for retinal vein occlusion and to examine the relationship to retinal morphology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
visual function (contrast sensitivity)
Key secondary outcomes
visual function (visual acuity,metamorphopsia, aniseikonia, stereopsis), number of injections, inter-injection period(number of recurrences, duration), vision-related quality of life, patient satisfaction
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who attended the Department of Ophthalmology of Nippon Medical School Hospital with BRVO or CRVO (central retinal thickness of 250 um or more) and are scheduled to receive farisimab injection treatment, and who have obtained consent for this study using the consent explanation document.
Key exclusion criteria
Patients with RVO in both eyes
Patients treated for the following CME within 90 days (steroid therapy, anti-VEGF injection, carbonic anhydrase inhibitor eye drops)
Patients undergoing endophthalmic surgery within 90 days
Patients undergoing intraocular photocoagulation within 30 days
Patients who have undergone vitrectomy.
Patients with moderate or severe cataract or refractive error that may affect visual function (Grade 3 or higher on the Emery-Little classification, etc.)
Patients with other ocular diseases
Patients with hypertensive or hyperglycemic emergencies
Patients who are judged to be inappropriate as research subjects by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Fumiki |
| Middle name | |
| Last name | Okamoto |
Organization
Nippon Medical School Hospital
Division name
Ophthalmology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
f-okamoto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Naka |
| Middle name | |
| Last name | Shiratori |
Organization
Nippon Medical School Hospital
Division name
Ophthalmology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
shiratori@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
CHUGAI 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
Ethics Committee of Nippon Medical Shool Hospital
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
nms_fuzokurinri@nms.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 | 26 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational, prospective, non-randomized, single institution study
Patients attending the Department of Ophthalmology, Nippon Medical School Hospital during the study period who meet the selection criteria and have given consent for this study will be included.
Management information
Registered date
| 2025 | Year | 02 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065281
