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Short‐term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients
Author(s) -
Kamei Motohiro,
Terasaki Hiroko,
Yoshimura Nagahisa,
Shiraga Fumio,
Ogura Yuichiro,
Grotzfeld Andrea Suhner,
Pilz Stefan,
Ishibashi Tatsuro
Publication year - 2017
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/aos.13196
Subject(s) - ranibizumab , medicine , retinal vein , ophthalmology , central retinal vein occlusion , occlusion , term (time) , macular edema , retinal , surgery , bevacizumab , chemotherapy , physics , quantum mechanics
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 μ m) 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.