Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients

Motohiro Kamei, Hiroko Terasaki, Nagahisa Yoshimura, Fumio Shiraga, Yuichiro Ogura, Andrea Suhner Grotzfeld, Stefan Pilz, Tatsuro Ishibashi

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Purpose: To evaluate the efficacy and safety of ranibizumab 0.5 mg in Japanese patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and to support the applicability of the phase III results from Caucasian to Japanese populations. Methods: This is a 3-month, open-label, single-arm, multicentre, phase III study. Thirty-one patients (15 BRVO and 16 CRVO) aged ≥18 years with a best-corrected visual acuity (BCVA) letter score of 19–73 (BRVO) or 24–73 (CRVO) were included. The primary end-point was the mean average change in BCVA from baseline to month 1 through month 3 after three consecutive monthly intravitreal injections of ranibizumab 0.5 mg. Secondary end-points were mean change in BCVA and central subfield thickness (CSFT), categorized BCVA, and safety over 3 months. Results: At month 3, the mean average change in BCVA improved substantially from baseline for BRVO (11.3 letters, p = 0.001) and CRVO (6.7 letters, p = 0.019). The mean BCVA improved (12.8 and 9.1 letters) and the mean CSFT decreased (212.5 and 442.1 μm) from baseline to month 3. At month 3, 26.7% (BRVO) and 31.3% (CRVO) of the patients had a gain of ≥15 letters from baseline. Safety findings in this study were similar to those reported in the previous clinical trials. Conclusion: Ranibizumab was effective in improving BCVA and was well tolerated in Japanese patients with BRVO and CRVO. The findings from this study were consistent with those reported in the Caucasian population.

Original languageEnglish
Pages (from-to)e29-e35
JournalActa Ophthalmologica
Volume95
Issue number1
DOIs
Publication statusPublished - Feb 1 2017

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Retinal Vein Occlusion
Macular Edema
Safety
Retinal Vein
Visual Acuity
Ranibizumab
Intravitreal Injections
Vision Disorders
Population

All Science Journal Classification (ASJC) codes

  • Ophthalmology

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Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients. / Kamei, Motohiro; Terasaki, Hiroko; Yoshimura, Nagahisa; Shiraga, Fumio; Ogura, Yuichiro; Grotzfeld, Andrea Suhner; Pilz, Stefan; Ishibashi, Tatsuro.

In: Acta Ophthalmologica, Vol. 95, No. 1, 01.02.2017, p. e29-e35.

Research output: Contribution to journalArticle

Kamei, Motohiro ; Terasaki, Hiroko ; Yoshimura, Nagahisa ; Shiraga, Fumio ; Ogura, Yuichiro ; Grotzfeld, Andrea Suhner ; Pilz, Stefan ; Ishibashi, Tatsuro. / Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients. In: Acta Ophthalmologica. 2017 ; Vol. 95, No. 1. pp. e29-e35.
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abstract = "Purpose: To evaluate the efficacy and safety of ranibizumab 0.5 mg in Japanese patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and to support the applicability of the phase III results from Caucasian to Japanese populations. Methods: This is a 3-month, open-label, single-arm, multicentre, phase III study. Thirty-one patients (15 BRVO and 16 CRVO) aged ≥18 years with a best-corrected visual acuity (BCVA) letter score of 19–73 (BRVO) or 24–73 (CRVO) were included. The primary end-point was the mean average change in BCVA from baseline to month 1 through month 3 after three consecutive monthly intravitreal injections of ranibizumab 0.5 mg. Secondary end-points were mean change in BCVA and central subfield thickness (CSFT), categorized BCVA, and safety over 3 months. Results: At month 3, the mean average change in BCVA improved substantially from baseline for BRVO (11.3 letters, p = 0.001) and CRVO (6.7 letters, p = 0.019). The mean BCVA improved (12.8 and 9.1 letters) and the mean CSFT decreased (212.5 and 442.1 μm) from baseline to month 3. At month 3, 26.7{\%} (BRVO) and 31.3{\%} (CRVO) of the patients had a gain of ≥15 letters from baseline. Safety findings in this study were similar to those reported in the previous clinical trials. Conclusion: Ranibizumab was effective in improving BCVA and was well tolerated in Japanese patients with BRVO and CRVO. The findings from this study were consistent with those reported in the Caucasian population.",
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T1 - Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients

AU - Kamei, Motohiro

AU - Terasaki, Hiroko

AU - Yoshimura, Nagahisa

AU - Shiraga, Fumio

AU - Ogura, Yuichiro

AU - Grotzfeld, Andrea Suhner

AU - Pilz, Stefan

AU - Ishibashi, Tatsuro

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AB - Purpose: To evaluate the efficacy and safety of ranibizumab 0.5 mg in Japanese patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and to support the applicability of the phase III results from Caucasian to Japanese populations. Methods: This is a 3-month, open-label, single-arm, multicentre, phase III study. Thirty-one patients (15 BRVO and 16 CRVO) aged ≥18 years with a best-corrected visual acuity (BCVA) letter score of 19–73 (BRVO) or 24–73 (CRVO) were included. The primary end-point was the mean average change in BCVA from baseline to month 1 through month 3 after three consecutive monthly intravitreal injections of ranibizumab 0.5 mg. Secondary end-points were mean change in BCVA and central subfield thickness (CSFT), categorized BCVA, and safety over 3 months. Results: At month 3, the mean average change in BCVA improved substantially from baseline for BRVO (11.3 letters, p = 0.001) and CRVO (6.7 letters, p = 0.019). The mean BCVA improved (12.8 and 9.1 letters) and the mean CSFT decreased (212.5 and 442.1 μm) from baseline to month 3. At month 3, 26.7% (BRVO) and 31.3% (CRVO) of the patients had a gain of ≥15 letters from baseline. Safety findings in this study were similar to those reported in the previous clinical trials. Conclusion: Ranibizumab was effective in improving BCVA and was well tolerated in Japanese patients with BRVO and CRVO. The findings from this study were consistent with those reported in the Caucasian population.

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