Session Title: AMD I
Session Date/Time: Thursday 26/09/2013 | 08:30-10:30
Paper Time: 08:30
Venue: Hall 1 (Level 2)
First Author: L.Kodjikian FRANCE
Co Author(s): E. Souied G. Mimoun M. Mauget-Faysse E. Decullier
To demonstrate the non-inferiority in terms of clinical efficacy of bevacizumab versus ranibizumab intravitreal injections for the treatment of neovascular age-related macular degeneration (AMD).
Multicenter French study involving 38 public and private-sector French ophthalmology centers.
GEFAL* is a non-inferiority head-to-head double-masked randomized clinical trial. Patients aged ≥ 50 years old were enrolled if they presented subfoveal neovascular AMD, with best-corrected visual acuity (BVCA) in the study eye of between 20/32 and 20/320 on the early treatment of diabetic retinopathy (ETDRS) chart, and a lesion area of less than 12 optic disk area. Patients were randomly assigned to one of the two study groups: intravitreal administration of bevacizumab (1.25 mg) or ranibizumab (0.50 mg). Hospital pharmacies were responsible for preparing, blinding and dispensing treatments. Patients were treated with a loading dose of 3 intravitreal injections during the first 3 months, followed by an as-needed regimen (one injection in case of active disease) for the remaining 9 months with monthly follow-up. The primary outcome was the change in visual acuity at one year. * “Groupe d’Etude Français Avastin versus Lucentis dans la DMLA néovasculaire” – French Study Group on Avastin versus Lucentis for neovascular AMD
501 patients have been included. The last patient-last visit occurred in November 2012. Statistical analyses are ongoing.
The GEFAL trial is a reliable double-masked study which respects the posology set out in the EMEA marketing authorization. GEFAL data will enhance the data currently available from head-to-head studies and may eventually help clinical decision-making for neovascular AMD.
The study was funded by the French grant scheme: “Programme Hospitalier de Recherche Clinique National 2008”. The French Ministry of Health financed the study and the French Health Insurance System financed the drugs.