One-year results from the first double-masked randomized control trial of Avastin for wet AMD

This week at the 2009 SOE Congress, Adnan Tufail, MD, of Moorfields Eye Hospital, reported one-year results showing Avastin dosed on a six-week schedule provided significant visual improvement compared to standard therapy.

The Avastin (bevacizumab) for choroidal neovascularisation (ABC) trial is a double-masked randomized controlled trial comparing intravitreal bevacizumab injections to standard therapy. Patients were randomized to intravitreal bevacizumab or standard therapy available at the time of trial initiation (verteporfin photodynamic therapy, intravitreal pegaptanib or sham treatment). Ranibizumab treatment was not included in the control arm as it had not been licensed for use at the start of recruitment for this trial.

The primary outcome was the proportion of patients gaining 15 or more letters of visual acuity at one year; secondary outcomes include the proportion of patients with stable vision and mean visual acuity change.

All lesion types were included. Each patient was treated with a loading dose of three consecutive injections six weeks apart. Re-treatment was guided by a 5 letter drop in vision or presence of any subretinal fluid.

At one year, 32.3 percent of the Avastin-treated group gained 15 or more letters of vision, compared with just 3 percent in the standard treatment group. Also, 46.2 percent gained 10 letters or more letters of vision. Most patients gained vision after the first injection. After the loading phase, they gained a mean of 6.6 letters. And the mean number of injections was 7.1.