The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients
Abstract The ZIPANGU study assessed the efficacy and safety of ranibizumab as a one loading dose + pro re nata (one + PRN) regimen with/without focal/grid laser among treatment-naïve patients suffering from macular edema (ME) following branch retinal vein occlusion (BRVO). ZIPANGU was a phase IV, pr...
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2021-01-01
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doaj-c1889e8f8f3f4171a6109becfb0e58672021-01-17T12:37:12ZengNature Publishing GroupScientific Reports2045-23222021-01-0111111110.1038/s41598-020-79051-1The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patientsToshinori Murata0Mineo Kondo1Makoto Inoue2Shintaro Nakao3Rie Osaka4Chieko Shiragami5Kenji Sogawa6Akikazu Mochizuki7Rumiko Shiraga8Yohei Ohashi9Takeumi Kaneko10Chikatapu Chandrasekhar11Akitaka Tsujikawa12Motohiro Kamei13Department of Ophthalmology, Shinshu University School of MedicineDepartment of Ophthalmology, Mie University Graduate School of MedicineDepartment of Ophthalmology, Kyorin Eye Center, Kyorin University School of MedicineDepartment of Ophthalmology, Graduate School of Medical Sciences, Kyushu UniversityDepartment of Ophthalmology, Kagawa University Faculty of MedicineDepartment of Ophthalmology, Kagawa University Faculty of MedicineDepartment of Ophthalmology, Asahikawa Medical UniversityNovartis Pharma K.K.Novartis Pharma K.K.Novartis Pharma K.K.Novartis Pharma K.K.Novartis Healthcare Pvt. Ltd.Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of MedicineDepartment of Ophthalmology, Aichi Medical UniversityAbstract The ZIPANGU study assessed the efficacy and safety of ranibizumab as a one loading dose + pro re nata (one + PRN) regimen with/without focal/grid laser among treatment-naïve patients suffering from macular edema (ME) following branch retinal vein occlusion (BRVO). ZIPANGU was a phase IV, prospective, randomized, open-label, active-controlled, 12-month, two-arm, multicenter study. Treatment-naïve patients with visual impairment (19–73 letters) caused by ME, defined as central subfield thickness (CSFT) > 300 µm, due to BRVO were randomly assigned to ranibizumab monotherapy (n = 29) or combination therapy (ranibizumab + focal/grid short-pulse laser, n = 30). The primary endpoint was the number of ranibizumab injections. Secondary endpoints were mean changes in best-corrected visual acuity (BCVA) and CSFT, and safety. There were no statistically significant differences in the mean number of ranibizumab injections between monotherapy (4.3 injections) vs. combination (4.1 injections) therapy, or in CSFT. BCVA improvement in the monotherapy arm (22.0 letters) was better than the combination therapy arm (15.0 letters) (p = 0.035). Overall, both regimens appeared to be safe and well tolerated. One + PRN ranibizumab is safe and efficacious in treatment-naïve patients with ME secondary to BRVO. A conjunctive laser treatment did not lead to better functional outcomes or fewer ranibizumab injections.https://doi.org/10.1038/s41598-020-79051-1 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Toshinori Murata Mineo Kondo Makoto Inoue Shintaro Nakao Rie Osaka Chieko Shiragami Kenji Sogawa Akikazu Mochizuki Rumiko Shiraga Yohei Ohashi Takeumi Kaneko Chikatapu Chandrasekhar Akitaka Tsujikawa Motohiro Kamei |
spellingShingle |
Toshinori Murata Mineo Kondo Makoto Inoue Shintaro Nakao Rie Osaka Chieko Shiragami Kenji Sogawa Akikazu Mochizuki Rumiko Shiraga Yohei Ohashi Takeumi Kaneko Chikatapu Chandrasekhar Akitaka Tsujikawa Motohiro Kamei The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients Scientific Reports |
author_facet |
Toshinori Murata Mineo Kondo Makoto Inoue Shintaro Nakao Rie Osaka Chieko Shiragami Kenji Sogawa Akikazu Mochizuki Rumiko Shiraga Yohei Ohashi Takeumi Kaneko Chikatapu Chandrasekhar Akitaka Tsujikawa Motohiro Kamei |
author_sort |
Toshinori Murata |
title |
The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients |
title_short |
The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients |
title_full |
The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients |
title_fullStr |
The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients |
title_full_unstemmed |
The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients |
title_sort |
randomized zipangu trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients |
publisher |
Nature Publishing Group |
series |
Scientific Reports |
issn |
2045-2322 |
publishDate |
2021-01-01 |
description |
Abstract The ZIPANGU study assessed the efficacy and safety of ranibizumab as a one loading dose + pro re nata (one + PRN) regimen with/without focal/grid laser among treatment-naïve patients suffering from macular edema (ME) following branch retinal vein occlusion (BRVO). ZIPANGU was a phase IV, prospective, randomized, open-label, active-controlled, 12-month, two-arm, multicenter study. Treatment-naïve patients with visual impairment (19–73 letters) caused by ME, defined as central subfield thickness (CSFT) > 300 µm, due to BRVO were randomly assigned to ranibizumab monotherapy (n = 29) or combination therapy (ranibizumab + focal/grid short-pulse laser, n = 30). The primary endpoint was the number of ranibizumab injections. Secondary endpoints were mean changes in best-corrected visual acuity (BCVA) and CSFT, and safety. There were no statistically significant differences in the mean number of ranibizumab injections between monotherapy (4.3 injections) vs. combination (4.1 injections) therapy, or in CSFT. BCVA improvement in the monotherapy arm (22.0 letters) was better than the combination therapy arm (15.0 letters) (p = 0.035). Overall, both regimens appeared to be safe and well tolerated. One + PRN ranibizumab is safe and efficacious in treatment-naïve patients with ME secondary to BRVO. A conjunctive laser treatment did not lead to better functional outcomes or fewer ranibizumab injections. |
url |
https://doi.org/10.1038/s41598-020-79051-1 |
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