Anat Loewenstein, MD (Tel Aviv, Israel),* MARINA and ANCHOR Study Group


Is Ranibizumab effective in the treatmentof CNV secondary to AMD?


Ranibizumab has been tested in two Phase III,randomized, multicenter, double-masked, controlled studies of patients with minimally classic or occult lesions(MARINA study, n?716) and predominantly classic lesions (ANCHOR study, n?423). Two year results are available for MARINA, and one-year results are available for ANCHOR.


The MARINA & ANCHOR Phase III studies met the10 efficacy endpoints, demonstrating that both ranibizumab doses were superior to sham & verteporfin PDT in maintaining & improving visual acuity (VA). In both studies, 94-95%of patients treated with ranibizumab 0.3mg & 95-96% of patients treated with 0.5mg lost <15 letters at month 12 (p<0.0001), vs 62% in the sham group (MARINA) & 64% in the PDT group (ANCHOR). This was independent of lesion type, size or baseline VA. Substantial mean improvements in VA over baseline were seen after the first ranibizumab treatment (both studies & doses) & maintained. In contrast a mean decline of 10 letters was observed in controls. More ranibizumab patients (25-40%) (both studies & doses) gained >15 letters at month 12 Vs controls (5-6%). Ranibizumab treated eyes showed stabilization of lesion size, reduction in leakage area by 2 disc areas (DA) Vs a 2 DA increase in lesion size & a 0.3-0.7 DA increase in leakage area in the control groups.


As shown in two independent Phase III studies, monthly ranibizumab 0.3mg or 0.5mg administered intravitreally to patients with neovascular AMD produced rapid improvements invision that were sustained for up to 2 years. The improvements in vision-related parameters are consistent across all CNV lesion types and patient subgroups.
* Financial interest disclosed