Unique ID issued by UMIN | UMIN000055074 |
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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 |
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
A comparative study of visual function, QOL, and satisfaction in patients with RVO, before and after switching to ranibizumab BS
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
A comparative study of visual function, QOL, and satisfaction in patients with RVO, before and after switching to ranibizumab BS
Japan |
Branch Retinal Vein Occlusion
Central Retinal Vein Occlusion
Ophthalmology |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Visual function (visual acuity)
Visual function (metamorphopsia, anisotropia, contrast sensitivity, stereopsis)
Number of ranibizumab BS injections, injection interval (number of recurrences, duration)
Vision-related QOL
Patient satisfaction
Observational
18 | years-old | < |
Not applicable |
Male and Female
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.
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
40
1st name | Fumiki |
Middle name | |
Last name | Okamoto |
Nippon Medical School Hospital
Ophthalmology
113-8603
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
03-3822-2131
f-okamoto@nms.ac.jp
1st name | Fumiki |
Middle name | |
Last name | Okamoto |
Nippon Medical School Hospital
Ophthalmology
113-8603
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
03-3822-2131
f-okamoto@nms.ac.jp
Nippon Medical School Hospital
Senju Pharmaceutical Co., Ltd.
Profit organization
Nippon Medical School Hospital
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
03-3822-2131
f-okamoto@nms.ac.jp
NO
2024 | Year | 07 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2024 | Year | 04 | Month | 24 | Day |
2024 | Year | 04 | Month | 24 | Day |
2024 | Year | 07 | Month | 25 | Day |
2026 | Year | 05 | Month | 31 | Day |
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.
2024 | Year | 07 | Month | 25 | Day |
2024 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062357
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