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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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/c1889e8f8f3f4171a6109becfb0e5867
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spelling	oai:doaj.org-article:c1889e8f8f3f4171a6109becfb0e58672021-12-02T14:12:08ZThe randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients10.1038/s41598-020-79051-12045-2322https://doaj.org/article/c1889e8f8f3f4171a6109becfb0e58672021-01-01T00:00:00Zhttps://doi.org/10.1038/s41598-020-79051-1https://doaj.org/toc/2045-2322Abstract 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.Toshinori MurataMineo KondoMakoto InoueShintaro NakaoRie OsakaChieko ShiragamiKenji SogawaAkikazu MochizukiRumiko ShiragaYohei OhashiTakeumi KanekoChikatapu ChandrasekharAkitaka TsujikawaMotohiro KameiNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q 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
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.
format	article
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
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 Portfolio
publishDate	2021
url	https://doaj.org/article/c1889e8f8f3f4171a6109becfb0e5867
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The randomized ZIPANGU trial of ranibizumab and adjunct laser for macular edema following branch retinal vein occlusion in treatment-naïve patients

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