Lucentis ranibizumab: Phase III data

The double-blind, international, Phase III RADIANCE trial in 277 patients with visual impairment due to CNV secondary to pathologic myopia showed that both dose regimens of 0.5 mg intravitreal Lucentis met the primary endpoint of improving mean BCVA score from baseline on the ETDRS eye chart at month 3 vs. verteporfin photodynamic therapy (vPDT). Lucentis was given on day 1 and then as needed guided by either BCVA stability criteria (group 1) or by disease activity criteria (group 2), while vPDT was given on day 1 followed by Lucentis as needed guided by disease activity criteria. Specifically, Lucentis improved mean BCVA from baseline to month 3 by 10.5 letters when guided by BCVA stability criteria and by 10.6 letters when guided by disease activity criteria vs. 2.2 letters for the vPDT regimen (p<0.00001 for both). Lucentis guided by disease activity criteria was non-inferior to Lucentis guided by BCVA stability criteria (p<0.00001).

On secondary endpoints, the Lucentis regimens improved mean BVCA from baseline to month 12 in group 1 (13.8 letters) and group 2 (14.4 letters) vs. the vPDT regimen (9.3 letters). The proportion of patients who gained >=10 letters from baseline to month 12 was 69.5% in group 1, 69% in group 2 and 49.1% in the vPDT group. The proportion of patients with CNV leakage at month 12 was 21% in group 1, 19% in group 2 and 29.1% in the vPDT group. At month 12, CRT declined from baseline by 66.6 µm in group 1 and 71.3 µm in group 2 vs. 60.8 µm in the vPDT group. Additionally, the mean number of Lucentis injections from day 1 to month 12 was 4.6 in group 1, 3.5 in group 2 and 3.2 in the vPDT group. No deaths or endophthalmitis cases and no new ocular/non-ocular safety findings with Lucentis were reported over 12 months. Data were presented at the European Society of Retina Specialists meeting in Hamburg. ...