Head-to-head GEFAL study confirms non-inferiority of bevacizumab

PARIS — A prospective, multicenter, randomized, double-masked study carried out in France proved the non-inferiority of bevacizumab to ranibizumab, confirming the previous finding of the CATT and other European head-to-head comparison studies.

The GEFAL (Groupe d’Evaluation Français Avastin versus Lucentis) study involved 46 hospitals and private clinics. It was an independent study financed with €4 million from the government and national insurance fund.

"This was a strong point of the study. Another advantage was that the study population reflected the real-life situation of AMD treatment in the country," Laurent Kodjikian, MD, PhD, said at the meeting of the French Society of Ophthalmology. "A third strong point was that it was performed everywhere in a double-masked fashion. Identical syringes, prepared by local hospital pharmacies, were used for Avastin (bevacizumab, Roche/Genentech) and Lucentis (ranibizumab, Novartis/Genentech)."

Laurent Kodjikian

In the two groups of 246 and 239 patients, respectively, the treatment regimen consisted of an induction phase with one monthly injection for 3 months followed by monthly monitoring and as-needed treatment. For both drugs, an average of seven injections over 1 year were used.

"Visual results were comparable, with a non-significant difference of 1.89 letters in favor of ranibizumab. A slightly better anatomical outcome, again non-significant, was obtained with ranibizumab. Both drugs showed the same pattern of rapid reduction in thickness up to 3 months, followed by stabilization with a small quantity of residual fluid," Kodjikian said.

A higher incidence of systemic side effects was reported with bevacizumab (1.6% vs. 0.8%).

"We need further data on individual complications and a risk-management plan for the use of bevacizumab," Kodjikian said.

Disclosure: Kodjikian is principal investigator of the trial and a member of the advisory board of Novartis.