June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Efficacy and safety of ranibizumab 0.5 mg in Asian patients with visual impairment due to macular edema secondary to branch retinal vein occlusion: results from the 12-month BLOSSOM study
Author Affiliations & Notes
  • wenbin wei
    Ophthalmology, Beijing Tongren Hospital, Beijing, China
  • Liansheng Zhu
    China Novartis Institutes for Biomedical Research Co., Ltd, Shanghai, China
  • Annemarie Weisberger
    Novartis Pharmaceuticals Corporation, East Hanover, East Hanover, New Jersey, United States
  • Yu Cheng
    China Novartis Institutes for Biomedical Research Co., Ltd, Shanghai, China
  • Chang Liu
    China Novartis Institutes for Biomedical Research Co., Ltd, Shanghai, China
  • Footnotes
    Commercial Relationships   wenbin wei, None; Liansheng Zhu, China Novartis Institutes for Biomedical Research Co., Ltd (E); Annemarie Weisberger, Novartis Pharmaceuticals Corporation (E); Yu Cheng, China Novartis Institutes for Biomedical Research Co., Ltd (E); Chang Liu, China Novartis Institutes for Biomedical Research Co., Ltd (E)
  • Footnotes
    Support  Novartis
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 4619. doi:
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      wenbin wei, Liansheng Zhu, Annemarie Weisberger, Yu Cheng, Chang Liu; Efficacy and safety of ranibizumab 0.5 mg in Asian patients with visual impairment due to macular edema secondary to branch retinal vein occlusion: results from the 12-month BLOSSOM study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4619.

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

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Abstract

Purpose : To assess the efficacy and safety of individualized intravitreal ranibizumab 0.5 mg in Asian (primarily Chinese) patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO).

Methods : A 12-month (M), Phase III, double-masked, randomized, sham-controlled, multicenter study. Patients aged ≥18 years were randomized 2:1 to receive either ranibizumab or sham. Patients received monthly consecutive intravitreal injections of ranibizumab until stable maximal visual acuity was achieved, followed by individualized, stabilization criteria-driven pro re nata (PRN) regimen. Patients in the sham group received monthly sham injections up to M2, followed by the PRN regimen up to M5. From M6, patients could receive ranibizumab PRN. The primary endpoint was the mean average change in best-corrected visual acuity (BCVA) from baseline (BSL) to M1 through M6. Secondary endpoints included mean changes in BCVA and central subfield thickness (CSFT) over time, treatment exposure, and safety over 12M.

Results : Of the 283 patients (ranibizumab, n=190; sham, n=93) randomized, 266 (94.0%) completed the study; 85.2% were Chinese. At BSL, patients’ mean age was 56.9 years, and the mean BCVA and CSFT were 57.4 letters and 525 μm, respectively. The ranibizumab PRN group was superior to sham from BSL to M1 through M6 (difference in least squares mean average change in BCVA: 7.5 letters [95% confidence interval: 5.3, 9.6], one-sided p<0.001 [Cochran-Mantel-Haenszel test]). The mean change in BCVA (Fig 1) and CSFT (Fig 2) was +16.4 letters and −273.4 μm with ranibizumab and +11.3 letters and −282.9 μm with sham, respectively, at M12. Over 12M, the mean number of injections in the study eye was 7.0 and 3.6 in the ranibizumab and sham groups, respectively. No deaths and no new safety findings were reported.

Conclusions : In Asian patients with BRVO, ranibizumab PRN was superior to sham with regard to early VA gains that were maintained throughout the study and CSFT reduction. In the sham group, where treatment with ranibizumab was commenced only from M6, at M12, the mean BCVA never reached the same level as in the ranibizumab group, showing the benefit of early treatment in achieving optimal visual outcomes. The safety profile of ranibizumab was consistent with previous ranibizumab studies for BRVO.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

 

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