DRUGS COMPARABLE

A multicentre French study comparing bevacizumab (Avastin, Genentech) and ranibizumab (Lucentis, Genentech) found that both drugs were comparable in terms of clinical efficacy for the treatment of neovascular age-related macular degeneration (AMD). Presenting the results of the Group d’Evaluation Français Avastin versus Lucentis (GEFAL) study at the 13th EURETINA Congress, Laurent Kodjikian MD of the University Hospital of Lyon, said that the outcomes are in line with those of the Comparison of AMD Treatment Trial (CATT) published in 2012. The GEFAL study was a prospective, double-masked, randomised study to evaluate the relative safety and efficacy of bevacizumab versus ranibizumab for the treatment of neovascular AMD. The study was conducted in 38 public and private- sector French ophthalmology centres from June 2009 to November 2011. A total of 501 patients aged 50 years or older were randomised to receive either 1.25mg of intravitreal bevacizumab (n = 255) or 0.50mg of ranibizumab (n = 246). Patients were treated with a loading dose of three intravitreal injections during the first three months, followed by an as-needed regimen, with one injection in case of active disease, for the remaining nine months with monthly follow-up.

In terms of the primary outcome, which was the change in best-corrected visual acuity at one year, bevacizumab was shown to be non-inferior to ranibizumab, Dr Kodjikian said. The mean visual acuity difference between the two drugs was 1.89 letters, which is clinically insignificant, nor was there any significant difference in adverse events between the groups, he concluded. Safety was a special focus of the GEFAL study, said Dr Kodjikian. Serious gastrointestinal events occurred in 1.2 per cent of bevacizumab-treated patients versus 2.1 per cent for ranibizumab. Three digestive haemorrhages occurred, all in the ranibizumab group in predisposed patients. In terms of serious infections, the overall rate was 1.6 per cent for bevacizumab versus 0.8 per cent for ranibizumab. Two cases of endophthalmitis were reported in a single patient in the ranibizumab group. Discussing the known weaknesses of the study, Dr Kodjikian cited the drop-out rate of around 20 per cent, which he said was anticipated in the sample size calculation. Despite this, he said that the GEFAL study had several strong points in its favour. “It was a double-masked trial, with identical masked syringes prepared by local hospital pharmacies and all ophthalmologists and patients were masked. Moreover, the primary outcomes were evaluated on the per protocol population and this was a truly representative population treated at public and private sites. Finally the study was independently funded by public grants,” he said.

In terms of take-home messages, Dr Kodjikian said that bevacizumab and ranibizumab were equivalent for visual acuity at final evaluation. A mean of seven injections was necessary within the year irrespective of the drug type being used. There was a rapid and substantial decrease in thickness and fluid with both drugs. While neither drug eliminated fluid in all eyes, more retinas were completely dry with ranibizumab. Furthermore, no statistical difference between the drugs was reported in terms of dye leakage on fluorescein angiography, although slightly less leakage was observed with ranibizumab. There was a slight decrease in CNV area with both drugs. Systemic or ocular serious adverse events were similar for both drugs.