A Phase 3 interventional study of Avastin and Lucentis in Age Related Macular Degeneration, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-05-28.
Sponsored by Hospices Civils de Lyon · Phase 3, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 501 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intravitreal injection of bevacizumab
Drug: Avastin
intravitreal injection of ranibizumab
Drug: Lucentis
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.
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
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon