French Evaluation Group Avastin Versus Lucentis (GEFAL)
Age Related Macular Degeneration (AMD) is the first cause of visual impairment in elderly patients in industrialized countries. Neovascular or "wet" AMD, characterized by the presence of choroïdal neovessels, represents the most aggressive form of the disease. Its prevalence is 3.3% among patients older than 65 years in Europe, and increases with age.
Intraocular injections of anti-angiogenic monoclonal antibodies (ranibizumab) to treat AMD have appeared recently. It is derived from a larger sized molecule, bevacizumab, which do not have the market authorization for this indication. However, numerous publications of case series seem to show the effectiveness and a satisfactory safety profile of bevacizumab.
These conclusions have to be confirmed with a high level of evidence study. The aim of the GEFAL study is to demonstrate non-inferiority of effectiveness in clinical terms after 12 months of treatment with bevacizumab compared to ranibizumab on the visual acuity of patients affected by neovascular AMD.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||French Evaluation Group Avastin Versus Lucentis|
- Evaluation of the mean change from inclusion to 12 months post initiation of treatment in VA score, measured on the "Early Treatment Diabetic Retinopathy Study" (ETDRS) scale at an initial distance of 4 meters. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Evaluate and compare the efficacy of treatments by bevacizumab and ranibizumab [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Evaluate and compare the proportion of adverse events occurring at the local and systemic level in the two groups. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Describe and compare the dosage regimen (average number of injections and time before re-injection) in the two groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Describe the pharmacokinetic profile of the drugs in blood and aqueous humor in a sub-group of 20 patients, during the induction stage. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Create a medico-economic model of the impact related to the two strategies. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
intravitreal injection of bevacizumab
Intravitreal injection of bevacizumab at a concentration of 1.25 mg per injection. One injection per month at the maximum and between 3 and 12 injection in the whole study.
Active Comparator: Lucentis
intravitreal injection of ranibizumab
Intravitreal injection of ranibizumab at a concentration of 0.50 mg per injection. One injection per month at the maximum and between 3 and 12 injection in the whole study.
|Service d'Ophtalmologie - Hôpital de la Croix Rousse|
|Lyon, France, 69317|
|Principal Investigator:||Laurent KODJIKIAN||Hospices Civils de Lyon - Hôpital de la Croix-Rousse|