http://www.evrs.eu/medias/2006/congress/Combined-Efficacy-of-Intravitreal-Ranibizumab-in-Two-Phase-III-Studies-of-Choroidal-Neovascularization-Secondary-to-Age-related-Macular-Degeneration.swf

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

PURPOSE:

Is Ranibizumab effective in the treatmentof CNV secondary to AMD?

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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