Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-28 @ 6:08 PM
Study NCT ID:
NCT01170767
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2010-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Evaluation Group Avastin Versus Lucentis
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
French Evaluation Group Avastin Versus Lucentis
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEFAL
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: