Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.
NCT06271330 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2025-01-16
Summary
Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \[1\] and aflibercept \[2\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \[3\] is that it extends the injection interval in the Treat and Extend (T\&E) protocol, which is more extensive than with previous anti-VEGF agents.
The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.
As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication.
Conditions
- Age-related Macular Degeneration
Interventions
- DRUG
-
Faricimab
switch from previous anti-VEGF agents to faricimab
Sponsors & Collaborators
-
Rennes University Hospital
collaborator OTHER -
Nantes University Hospital
lead OTHER
Principal Investigators
-
Jean-Baptiste Ducloyer, M.D · Nantes University Hospital
-
Yann Maucourant, M.D · CHU Rennes
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2025-04-01
- Completion
- 2026-09-30
Countries
- France
Study Locations
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