EXTEND-I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Acta Ophthalmol. 2010 May;88(3):309-16. doi: 10.1111/j.1755-3768.2009.01843.x. Epub 2010 Feb 16.

Abstract

Purpose: To evaluate the efficacy and safety of intravitreal ranibizumab for subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in Japanese patients.

Methods: This open-label, multicentre, Phase I/II study enroled patients into Group A (single injection of ranibizumab nonrandomized doses of 0.3 or 0.5 mg followed by 11 monthly injections of the same dose) and Group B (12 monthly injections of ranibizumab randomized to 0.3 or 0.5 mg). The primary efficacy endpoint was the mean change from baseline in best-corrected visual acuity (BCVA) score at Month 6. Safety was evaluated in all patients who received ranibizumab.

Results: Of 88 patients enroled, 12 entered Group A (six per dose) and 76 entered Group B (0.3 mg: n = 35; 0.5 mg: n = 41). Mean change from baseline in BCVA was significantly increased for both doses (Group B) at Month 6 (0.3 mg: +8.1 letters, p = 0.0006; 0.5 mg: +9.0 letters, p < 0.0001) and Month 12 (0.3 mg: +9.5 letters, p = 0.0001; 0.5 mg: +10.5 letters, p < 0.0001). At Month 12, one patient (0.3 mg) and 0 patients (0.5 mg) lost > or =15 letters, while 37.1% (0.3 mg) and 31.7% (0.5 mg) of patients gained > or =15 letters. Ocular serious adverse events (SAEs) of the study eye were reported in 1 and 2 patients in the 0.3- and 0.5-mg groups, respectively. Nonocular SAEs were experienced by 2 and 5 patients in the 0.3- and 0.5-mg groups, respectively. No cases of endophthalmitis were reported.

Conclusion: Ranibizumab was effective and well tolerated in Japanese patients with subfoveal CNV secondary to AMD.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angiogenesis Inhibitors / administration & dosage*
  • Angiogenesis Inhibitors / adverse effects
  • Angiogenesis Inhibitors / pharmacokinetics
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal, Humanized
  • Asian Continental Ancestry Group / ethnology
  • Choroidal Neovascularization / drug therapy*
  • Choroidal Neovascularization / ethnology
  • Choroidal Neovascularization / etiology
  • Female
  • Fovea Centralis
  • Humans
  • Japan / epidemiology
  • Macular Degeneration / complications
  • Macular Degeneration / drug therapy*
  • Macular Degeneration / ethnology
  • Male
  • Ranibizumab
  • Retreatment
  • Treatment Outcome
  • Visual Acuity / physiology

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Ranibizumab