Two-year safety and efficacy results in ANCHOR favor ranibizumab over PDT in AMD

KOLOA, Hawaii — Two-year results of a phase 3 trial have shown that ranibizumab helps maintain vision — with few adverse effects — better than photodynamic therapy in patients with wet age-related macular degeneration.

The results of the ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD) trial were announced here by Peter K. Kaiser, MD, at Retina 2007, held in conjunction with Hawaiian Eye 2007.

"The safety in the ANCHOR study is consistent with that of the MARINA [trial] 2-year results and other ranibizumab trials," said Dr. Kaiser, an OSN Retina/Vitreous Section Member. "More importantly, there was a statistically significant benefit over PDT in predominantly classic CNV maintained from month 12 to month 24."

The study included 423 patients randomized to receive 0.3 mg or 0.5 mg of ranibizumab along with sham verteporfin PDT or sham injections plus active verteporfin PDT. Treatments were performed monthly over 2 years.

Patients included in the study had predominantly classic choroidal neovascularization secondary to age-related macular degeneration and had not received any prior PDT treatments.

Dr. Kaiser said 90% of patients in both ranibizumab (Lucentis, Novartis/QLT) groups lost less than 15 letters of visual acuity, compared with 65.7% of patients in the PDT group.

Visual acuity improved a mean of 11 letters compared with baseline in the ranibizumab groups; 34% to 41% of patients improved more than 15 letters and 9% to 14% of patients improved more than 30 letters.

Nearly 78% of patients in the ranibizumab groups maintained baseline visual acuity or gained some letters, compared to 28.7% in the PDT group, Dr. Kaiser said.

Patients who achieved 20/20 or better were: 9.3% in the group that received 0.5 mg of ranibizumab, and 4.3% in the group that received 0.3 mg, compared to 0.7% in the PDT group.

Dr. Kaiser said there "was a low rate of serious adverse events." He said there was approximately a 2% incidence of endophthalmitis, which he said is not surprising, considering the injections are intravitreous.

Seven experienced non-ocular hemorrhage, six of whom took anticoagulants. Dr. Kaiser said this could have been related.

"The study was not designed to find small safety issues. We need to continue to follow these patients," he said.

He and other faculty members encouraged audience members to report their findings to MedWatch. ANCHOR concludes with these data, but all patients are enrolled in the extension trial, HORIZON.