SAILOR study shows safe, good visual results for ranibizumab in treating neovascular AMD

Ophthalmology. 2009;116(9):1731-1739.

Ranibizumab had a beneficial effect on visual outcome, along with safe and well-tolerated results, in treating neovascular age-related macular degeneration, a study found.

"Intravitreal ranibizumab was safe and well-tolerated in a large population of subjects with neovascular AMD," the authors said. "Ranibizumab had a beneficial effect on [visual acuity]."

The study is known as the Safety Assessment of Intravitreous Lucentis for AMD, or SAILOR. It is a phase 3b follow-up to the MARINA and ANCHOR studies and the first phase 3 trial to look at "individualized, criteria-based re-treatment."

The SAILOR study had two cohorts totaling 4,300 subjects. All patients had subfoveal choroidal neovascularization secondary to AMD.

In cohort one, 2,378 patients were randomized at a 1:1 ratio to receive either a 0.3 mg or 0.5 mg intravitreal injection of Lucentis (ranibizumab, Genentech) at 3-month doses. Re-treatment was based on optical coherence tomography results and visual acuity criteria.

In cohort two, 1,922 patients were given an intravitreal dose of 0.5 mg of ranibizumab and further treatment "at physician discretion."

The study found that rates of individual key ocular serious adverse events in both cohorts were less than 1%.

At 12 months, treatment-na?ve patients in cohort one had a average gain of 0.5 visual acuity letters in the 0.3 mg group and 2.3 letters in the 0.5 mg group. Previously treated patients in cohort one had gained 1.7 letters of visual acuity in the 0.3 mg group and 2.3 letters in the 0.5 mg group.

In cohort two, Snellen results improved from a median of 20/100 at baseline to 20/80 at 12 months. However, those results were affected by a low follow-up rate, the authors said.