June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Comparison of ranibizumab with or without focal/grid laser for macular edema secondary to branch retinal vein occlusion: 12-month results from the ZIPANGU study
Author Affiliations & Notes
  • Toshinori Murata
    Shinshu University, Japan
  • Mineo Kondo
    Mie University Graduate School of Med, Japan
  • Makoto Inoue
    Kyorin Eye Center, Japan
  • Shintaro Nakao
    Kyushu University, Japan
  • Rie Osaka
    Kagawa University Faculty of Medicine, Japan
  • Chieko Shiragami
    Kagawa University Faculty of Medicine, Japan
  • Kenji Sogawa
    Asahikawa Medical University, Japan
  • Akikazu Mochizuki
    Novartis Pharma K.K., Japan
  • Rumiko Shiraga
    Novartis Pharma K.K., Japan
  • Yohei Ohashi
    Novartis Pharma K.K., Japan
  • Takeumi Kaneko
    Novartis Pharma K.K., Japan
  • Akitaka Tsujikawa
    Kyoto University Graduate School of Med, Japan
  • Motohiro Kamei
    Aichi Medical University, Japan
  • Footnotes
    Commercial Relationships   Toshinori Murata, Bayer (F), Carl Zeiss Meditec (F), Novartis Pharma (F); Mineo Kondo, Novartis Pharma (F); Makoto Inoue, Alcon Japan (F); Shintaro Nakao, [P] 2016-213815 (P), Bayer (F), Kowa Company. Ltd (F), Novartis Pharma K.K. (F); Rie Osaka, None; Chieko Shiragami, Bayer (R), Novartis Pharma (F), Novartis Pharma (R); Kenji Sogawa, Regeneron (F); Akikazu Mochizuki, Novartis Pharma (E); Rumiko Shiraga, Novartis Pharma (E); Yohei Ohashi, Novartis Pharma (E); Takeumi Kaneko, Novartis Pharma (E); Akitaka Tsujikawa, Alcon Japan Ltd (F), Alcon Japan Ltd (R), AMO Japan (F), Bayer (F), Bayer (R), Canon (F), HOYA  (F), Japan Medical Industry Association (F), Kowa Company. Ltd (F), Novartis Pharma (F), Novartis Pharma K.K. (R), Pfizer Pharmaceuticals (F), Santen Pharmaceutical (F), Santen Pharmaceutical (R), Senju Pharmaceutical CO., LTD (F), Senju Pharmaceutical CO., LTD (R), WAKAMOTO PHARMACEUTICAL CO., LTD. (F); Motohiro Kamei, Alcon Japan Ltd (F), AMO Japan (F), HOYA CORPORATION (F), Japan Contact Lens (F), Kowa Company. Ltd (F), Novartis Pharma K.K. (F), Otsuka Pharmaceutical Co., Ltd. (F), Pfizer Pharmaceuticals (F), Santen Pharmaceutical (F), Senju Pharmaceutical CO., LTD (F), WAKAMOTO PHARMACEUTICAL CO., LTD. (F)
  • Footnotes
    Support  The research was supported and funded by Novartis Pharma K.K., Tokyo, Japan.
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 3522. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Toshinori Murata, Mineo Kondo, Makoto Inoue, Shintaro Nakao, Rie Osaka, Chieko Shiragami, Kenji Sogawa, Akikazu Mochizuki, Rumiko Shiraga, Yohei Ohashi, Takeumi Kaneko, Akitaka Tsujikawa, Motohiro Kamei; Comparison of ranibizumab with or without focal/grid laser for macular edema secondary to branch retinal vein occlusion: 12-month results from the ZIPANGU study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):3522.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : The ZIPANGU study is the first phase IV, prospective, randomized, 12-month, multicenter study for macular edema secondary to branch retinal vein occlusion (BRVO) in Japanese patients. The purpose of this study was to minimize the required number of ranibizumab (RBZ) injections while maintaining vision restoring efficacy. We tested whether 1+PRN RBZ combined with focal/grid short pulse laser (RBZ+laser arm) can reduce the number of RBZ injections compared with those for 1+PRN RBZ monotherapy (RBZ arm).

Methods : In this study, 59 patients were randomized (1:1) to the RBZ or RBZ+laser arm. Patients received 1+PRN RBZ and laser treatment applied to the affected area, which corresponded to capillary dropout within vascular arcades. RBZ PRN criteria was defined by meeting any one or more of the following conditions: central subfield foveal thickness (CSFT) ≥300 μm, ≥20% increase from the lowest value in CSFT, decrease in visual acuity (VA) due to disease activity. The difference in the mean number of RBZ injections over 12 months (primary endpoint) and the mean change of VA, CSFT, and safety of the two treatment arms (secondary endpoints) were evaluated.

Results : The mean number of RBZ injections in the RBZ and RBZ+laser arms was not statistically different (4.3±0.5 and 4.1±0.4, respectively, p=0.432). VA (ETDRS letters) improved in both arms at 12 months compared with baseline (from 52.9±2.5 to 74.8±1.8 and from 54.0±1.8 to 69.6±1.6, respectively, p<0.01) and was significantly better in the RBZ than in the RBZ+laser arm (+22.0±2.7 vs +15.0±1.9, p=0.035). CSFT also improved in both arms at 12 months compared with baseline (from 563.3±27.3 to 257.0±8.1 and from 553.3±33.3 to 285.1±15.4, respectively, p<0.01). No serious ocular adverse events occurred.

Conclusions : The ZIPANGU study showed that 1+PRN RBZ combined with laser therapy did not reduce the mean number of RBZ injections. However, the 1+PRN regimen suggested that four RBZ injections per year, which is fewer than that in previous clinical trials of RBZ, BRAVO (8.4 ranibizumab injections, +18.3 letters improvement/year), and the BRIGHTER studies (11.4 ranibizumab injections, +15.5 letters improvement/2year), led to similar VA improvement. (ClinicalTrials.gov: NCT02953938)

This is a 2020 ARVO Annual Meeting abstract.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×