French Evaluation Group Avastin Versus Lucentis (GEFAL)
|ClinicalTrials.gov Identifier: NCT01170767|
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : July 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Drug: Avastin Drug: Lucentis||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||501 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||French Evaluation Group Avastin Versus Lucentis|
|Study Start Date :||June 2009|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
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.
- 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 ]
- Evaluate and compare the efficacy of treatments by bevacizumab and ranibizumab [ Time Frame: 12 months ]
- Evaluate and compare the proportion of adverse events occurring at the local and systemic level in the two groups. [ Time Frame: 12 months ]
- Describe and compare the dosage regimen (average number of injections and time before re-injection) in the two groups [ Time Frame: 12 months ]
- 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 ]
- Create a medico-economic model of the impact related to the two strategies. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170767
|Service d'Ophtalmologie - Hôpital de la Croix Rousse|
|Lyon, France, 69317|
|Principal Investigator:||Laurent KODJIKIAN||Hospices Civils de Lyon - Hôpital de la Croix-Rousse|