Age-related Macular Degeneration
Conditions
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.
Interventions
DRUGFaricimab
switch from previous anti-VEGF agents to faricimab
Sponsors
Nantes University Hospital
Rennes University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment. | 1 year | number of week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between time to recurrence before switch and after switch. | 1 year | time to recurrence in weeks |
Countries
France
Contacts
CONTACTJean-Baptiste Ducloyer, M.D
CONTACTAlexandra Poinas, PhD
PRINCIPAL_INVESTIGATORJean-Baptiste Ducloyer, M.D
Nantes University Hospital
PRINCIPAL_INVESTIGATORYann Maucourant, M.D
Rennes University Hospital
Outcome results
None listed