NCT06271330 Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.
| NCT ID | NCT06271330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Age-related Macular Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-04-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Male or female patient of legal age (≥18 years) with exudative AMD treated with IVT ranibizumab or aflibercept \> 1 year. * Patient whose IVT injection interval is strictly less than 12 weeks. Exclusion Criteria: * Severe myopia (axial length \> 26 mm or sphere \< - 6 dioptres). * Presence of angioid striae. * Presence of moderate or more severe diabetic retinopathy. * History of diabetic macular edema. * History of uveitis. * Previous retinal vein occlusion (branch or central vein). * History of pseudovitelliform macular dystrophy. * Patient under guardianship or trusteeship * Pregnant or breast-feeding woman