EXTEND III: Efficacy and safety of ranibizumab in South Korean and Taiwanese patients with subfoveal CNV secondary to AMD

Oh Woong Kwon, Fenq Lih Lee*, Hum Chung, Chi Chun Lai, Shwu Jiuan Sheu, Young Hee Yoon

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

11 Scopus citations

Abstract

Background The purpose of this study was to investigate the efficacy and safety of intravitreal ranibizumab 0.5 mg in South Korean and Taiwanese patients with subfoveal choroidal neovascularization (CNV) secondary to agerelated macular degeneration (AMD). Methods This was a 12-month, open-label, single-arm, multicenter, phase III study. Ninety-five patients (Taiwanese: 51; South Korean: 44) were included in the study. Key outcome measures assessed included: mean change in best-corrected visual acuity (BCVA) from baseline to months 4 (primary endpoint) and 12 (secondary endpoint); other secondary endpoints comprising categorized mean change in BCVA from baseline at month 4 and month 12, mean change in BCVA from baseline at month 4 and month 12 per baseline characteristics; and incidence of ocular and non-ocular adverse events and serious adverse events (SAEs) at month 12. Results The mean BCVA change improved significantly (p<0.0001) from baseline to both month 4 (+9.3 letters) and month 12 (+10.1 letters). At month 12, the proportion of patients who gained ≥5, 10, or 15 letters from baseline was 75.8%, 54.7%, and 32.6% respectively. Total and CNV lesion area significantly decreased from baseline (p<0.0001). About 57% of patients showed complete absence of fluorescein leakage atmonth 12.Mean change frombaseline visual acuity scores also increased significantly over time for all subgroups. At month 12, ocular SAEs occurred in 2.1% of patients (out of which one patient [1.1%] experienced endophthalmitis) and 16.8% of patients experienced non-ocular SAEs. There were no deaths reported during the study. Conclusions Consistent with previous studies in Caucasian and Japanese populations, EXTEND III confirms that monthly intravitreal injections of ranibizumab 0.5 mg administered over 12 months is effective and well-tolerated in South Korean and Taiwanese patients with subfoveal CNV secondary to AMD.

Original languageEnglish
Pages (from-to)1467-1476
Number of pages10
JournalGraefe's Archive for Clinical and Experimental Ophthalmology
Volume250
Issue number10
DOIs
StatePublished - 10 2012
Externally publishedYes

Keywords

  • Age-related macular degeneration
  • Best-corrected visual acuity
  • Choroidal neovascularization
  • Fluorescein leakage
  • Intravitreal ranibizumab

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