UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055682 |
|---|---|
| Receipt number | R000063630 |
| Scientific Title | Study of Visual Function and Vision-Related Quality of Life Before and After Vitreous Injection of Faricimab in Diabetic Macular Edema |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/10/01 23:07:10 |
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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 Diabetic Macular Edema
Acronym
Study of Visual Function-Related QOL Before and After Faricimab Injection in DME
Scientific Title
Study of Visual Function and Vision-Related Quality of Life Before and After Vitreous Injection of Faricimab in Diabetic Macular Edema
Scientific Title:Acronym
Study of Visual Function-Related QOL Before and After Faricimab Injection in DME
Region
| Japan |
Condition
Condition
Diabetic macular edema
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 vision-related quality of life before and after treatment in patients treated with injections of faricimab for DME 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 have attended the Department of Ophthalmology of Nippon Medical School Hospital with DME (central retinal thickness of 250 um or more) and have been treated with faricimab injection therapy, who have explained about this study using a written consent explanation and obtained consent.
Key exclusion criteria
If the patient has DME in both eyes, the condition of the other eye is worse than that of the study eye.
History of vitreoretinal surgery (including scleral encircling) or endophthalmitis
Patients who have undergone any ocular procedure (vitreoretinal photocoagulation, vitreous steroid injection, or sub-tenon steroid injection) within 90 days of the scheduled first dose of faricimab
Treatment with anti-VEGF agent within 90 days of the scheduled first dose of faricimab
Active ocular disease (proliferative diabetic retinopathy, uveitis, iris angiogenesis, vitreous hemorrhage, etc.)
Patients with a history of ophthalmic surgery (cataract surgery, posterior capsulotomy, or any other intraocular surgery) within the past 90 days.
Aphakia
Patients with decreased visual acuity (vitreomacular traction, macular atrophy, etc.) not caused by edema
Glaucoma with poorly controlled intraocular pressure (IOP of 25 mmHg or higher) in the study eye, previous or potential filtration surgery for glaucoma
Myopia of -8D or greater
Significantly poor visual function in eyes not enrolled in the study
Poorly controlled diabetes mellitus (HbA1c > 12.0%)
Poorly controlled hypertension (systolic >= 160, diastolic >= 95 mmHg)
Systemic disease (severe infection, renal failure, heart failure, cerebrovascular disease) that would require the administration of drugs that may affect the results of this study
Pregnant or lactating women
Women who wish to have a baby but do not wish to use contraception during the study period.
Drug hypersensitivity to fluorescein or faricimab
Participation in another interventional study
Patients judged to be inappropriate by the research director
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, 113-8603, Japan.
TEL
03-3822-2131
f-okamoto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Nakano |
Organization
Nippon Medical School Hospital
Division name
Ophthalmology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
TEL
03-3822-2131
Homepage URL
n-yuji@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 School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, 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
| 2024 | Year | 10 | Month | 01 | 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
9
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
| 2024 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 obtained consent for this study will be included.
Management information
Registered date
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063630
