UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055074 |
|---|---|
| Receipt number | R000062357 |
| Scientific Title | A comparative study of visual function, QOL, and satisfaction in patients with BRVO or CRVO macular edema being treated with existing anti-VEGF agents, before and after switching to ranibizumab BS |
| Date of disclosure of the study information | 2024/07/25 |
| Last modified on | 2024/07/25 17:43:36 |
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Basic information
Public title
A comparative study of visual function, QOL, and satisfaction in patients with BRVO or CRVO macular edema being treated with existing anti-VEGF agents, before and after switching to ranibizumab BS
Acronym
A comparative study of visual function, QOL, and satisfaction in patients with RVO, before and after switching to ranibizumab BS
Scientific Title
A comparative study of visual function, QOL, and satisfaction in patients with BRVO or CRVO macular edema being treated with existing anti-VEGF agents, before and after switching to ranibizumab BS
Scientific Title:Acronym
A comparative study of visual function, QOL, and satisfaction in patients with RVO, before and after switching to ranibizumab BS
Region
| Japan |
Condition
Condition
Branch Retinal Vein Occlusion
Central Retinal Vein Occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare visual function, QOL, and satisfaction in patients with BRVO or CRVO, before and after switching from existing anti-VEGF agents to ranibizumab BS.
The purposes of this study are to clarify the non-inferiority of ranibizumab BS to existing anti-VEGF agents in efficacy, and the relationship between the visual acuity and vision-related QOL of ranibizumab BS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual function (visual acuity)
Key secondary outcomes
Visual function (metamorphopsia, anisotropia, contrast sensitivity, stereopsis)
Number of ranibizumab BS injections, injection interval (number of recurrences, duration)
Vision-related QOL
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 attend to the ophthalmology department of Nippon Medical School Hospital who diagnosed with BRVO or CRVO, had been treated with existing anti-VEGF agents for the past 6 months, and request to switch to ranibizumab BS.
Key exclusion criteria
Moderate or higher myopia/cataract
Patients with eye diseases that impair visual function other than vitreoretinal diseases
Patients who have undergone other intraocular surgery
Patients for whom no CME reduction effect is observed with existing anti-VEGF agents
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 | 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
Homepage URL
f-okamoto@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Senju 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
Nippon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Tel
03-3822-2131
f-okamoto@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 | 07 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study
Recruitment method: Patients who visit our hospital from the date of study permission till May 31, 2026, who meet the criteria, and give informed consent to participate in the study.
Measurement items: Visual function, vision-related QOL, patient satisfaction, etc.
Management information
Registered date
| 2024 | Year | 07 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062357
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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