UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057397 |
|---|---|
| Receipt number | R000064719 |
| Scientific Title | A study investigating the efficacy of a modified treat-and-extend regimen with intravitreal faricimab injections for macular edema secondary to branch retinal vein occlusion. |
| Date of disclosure of the study information | 2025/03/25 |
| Last modified on | 2026/07/07 18:01:43 |
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Basic information
Public title
A study investigating the efficacy of a modified treat-and-extend regimen with intravitreal faricimab injections for macular edema secondary to branch retinal vein occlusion.
Acronym
A study investigating the efficacy of a mTAE with IVF for ME secondary to BRVO.
Scientific Title
A study investigating the efficacy of a modified treat-and-extend regimen with intravitreal faricimab injections for macular edema secondary to branch retinal vein occlusion.
Scientific Title:Acronym
A study investigating the efficacy of a mTAE with IVF for ME secondary to BRVO.
Region
| Japan |
Condition
Condition
macular edema secondary to branch retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the 2-year visual acuity improvement and retinal thickness change, number of doses and number of hospital visits for macular edema associated with retinal vein occlusion using the modified treat and extend method of intravitreal farisimab for macular edema, in one uncontrolled group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best corrected visual acuity and central area retinal thickness at 1 and 2 years after the start of treatment
Key secondary outcomes
The number of drug administrations, the number of outpatient visits, and the proportion of patients who were able to discontinue medication over 2 years, as well as the number of microaneurysms observed in fluorescein fundus angiography at 3 months, 1 year, and 2 years.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Untreated macular edema secondary to branch retinal vein occlusion within one year of onset (central retinal thickness 320 micro meter or more)
Willing to receive treatment
Agreement to this study
Key exclusion criteria
History of anti-VEGF drug vitreous injection or steroid tenon subcapsular injection/vitreous injection
History of internal ocular surgery within 3 months
Presence of other diseases causing vision loss
Previous vitrectomy
Previous lattice photocoagulation
Fellow eye is already included in the study (if both eyes are involved, the one with the larger area of occlusion will be included)
Previous cerebrovascular event within 3 months
Physician's judgment that the patient is not suitable for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Department of Ophthalmology
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL
0285-58-7382
takahah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Jichi Medical University
Division name
Department of Ophthalmolo
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL
0285-58-7382
Homepage URL
takahah-tky@umin.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Jichi Medical University Central Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
Tel
0285-58-8933
rinri@jichi.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
新小山市民病院（栃木県）、芳賀赤十字病院（栃木県）、佐野メディカルセンター佐野市民病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 25 | 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
15
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 | 07 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2030 | 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, multicenter study
Patients who attend the Department of Ophthalmology of Jichi Medical School Hospital, Shin-Oyama City Hospital, Haga Redcross Hospital, and Sano City Hospital during the study period, meet the selection criteria, and agree to participate in this study are eligible.
Management information
Registered date
| 2025 | Year | 03 | Month | 25 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064719
