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


CONCLUSIONS
Ranibizumab was effective and well tolerated in Japanese patients with subfoveal CNV secondary to AMD.
Tano
Yasuo
Y
Department of Ophthalmology, Osaka University Medical School, Japan.
Ohji
Masahito
M
D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D061067:Antibodies, Monoclonal, Humanized; D044466:Asian People / Q000208:ethnology; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000208:ethnology / Q000209:etiology; D005260:Female; D005584:Fovea Centralis; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008268:Macular Degeneration / Q000150:complications / Q000188:drug therapy* / Q000208:ethnology; D008297:Male; D000069579:Ranibizumab; D019233:Retreatment; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab