ANCHOR study 2-year results consistent with earlier data

The 2-year safety and efficacy results are consistent with the 1-year ANCHOR (ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD) data and the 2-year MARINA (Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab In the treatment of Neovascular AMD) data. In ANCHOR, there was a statistically significant benefit of ranibizumab compared with verteporfin (Visudyne, Novartis Ophthalmics) photodynamic therapy (PDT) in predominantly classic choroidal neovascularization (CNV).

The ANCHOR study is a randomized, multicenter, double-masked, active treatment-controlled study designed to evaluate the effect of ranibizumab compared with verteporfin PDT in patients with predominantly classic neovascular AMD. The study was international, with 71 centers in the United States, eight in Europe, and four in Australia, and ran from June 2003 to September 2006.

The primary endpoint of the study was the proportion of patients who lost fewer than 15 letters in the best-corrected visual acuity (VA) score at 12 months compared with baseline, based on the ETDRS visual acuity chart at a starting test distance of 2 m.

Results at 24 months

Dr. Heier reported that at month 24, 65.7% of patients treated with PDT, 90.0% of those treated with 0.3 mg ranibizumab, and 89.9% of those treated with 0.5 mg ranibizumab lost fewer than 15 letters compared with baseline. These results were very similar to the 12-month results of 64.3%, 94.3%, and 96.4%, respectively. All of the ranibizumab results were significantly (p < 0.0001) better compared with PDT.

The evaluation of the secondary endpoints also showed that ranibizumab resulted in better visual outcomes. The percentages of patients who gained 15 or more letters from baseline at month 24 were 6.3%, 34.3%, and 41.0%, respectively, in the PDT group, the 0.3-mg ranibizumab group, and the 0.5-mg ranibizumab group. All of the ranibizumab results were significantly (p < 0.0001) better compared with PDT. Again, these results were very similar to the 12-month results of 5.6%, 35.7%, and 40.3%, respectively.