The aim of the GEFAL trial was to evaluate the relative efficacy and safety profile of Bevacizumab ( Avastin ) versus Ranibizumab ( Lucentis ) intravitreal injections for the treatment of neovascular age-related macular degeneration ( AMD ).
The multicenter, prospective, noninferiority, double-masked, randomized clinical trial was performed in 38 French ophthalmology centers.
The noninferiority limit was 5 letters.
Patients aged greater than or equal to 50 years were eligible if they presented with subfoveal neovascular age-related macular degeneration, with best-corrected visual acuity ( BVCA ) in the study eye of between 20/32 and 20/320 measured on the ETDRS chart and a lesion area of less than 12 optic disc areas.
Patients were randomly assigned to intravitreal administration of Bevacizumab ( 1.25 mg ) or Ranibizumab ( 0.50 mg ).
Hospital pharmacies were responsible for preparing, blinding, and dispensing treatments.
Patients were followed for 1 year, with a loading dose of 3 monthly intravitreal injections, followed by an as-needed regimen ( 1 injection in case of active disease ) for the remaining 9 months with monthly follow-up.
The main outcome measure was mean change in visual acuity at 1 year.
During the period 2009-2011, 501 patients were randomized.
In the per protocol analysis, Bevacizumab was noninferior to Ranibizumab ( Bevacizumab minus Ranibizumab +1.89 letters; P less than 0.0001 ).
The intention-to-treat analysis was concordant.
The mean number of injections was 6.8 in the Bevacizumab group and 6.5 in the Ranibizumab group ( P=0.39 ).
Both drugs have reduced the central subfield macular thickness, with a mean decrease of 95 microm for Bevacizumab and 107 microm for Ranibizumab ( P=0.27 ).
There were no significant differences in the presence of subretinal or intraretinal fluid at final evaluation, dye leakage on angiogram, or change in choroidal neovascular area.
The proportion of patients with serious adverse events was 12.6% in the Bevacizumab group and 12.1% in the Ranibizumab group ( P=0.88 ).
The proportion of patients with serious systemic or ocular adverse events was similar in both groups.
In conclusion, Bevacizumab was noninferior to Ranibizumab for visual acuity at 1 year with similar safety profiles. Ranibizumab tended to have a better anatomic outcome. The results are similar to those of previous head-to-head studies. ( Xagena )
Kodjikian L et al, Ophthalmology 2013; 120: 2300-2309