Clinical trial NCT06271330: Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.
Official title: A Multicenter Real-life Observational Retrospective Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With Refractory or Dependent Exudative AMD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age-related Macular Degeneration
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Rennes University Hospital
First posted: 2024-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will retrospectively compare data from patients switched at centers in western France between the time of switch and 6 months after switch.

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

Primary outcomes:
measure: Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment.
timeFrame: 1 year
Secondary outcomes:
measure: Difference between time to recurrence before switch and after switch.
timeFrame: 1 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: Ducloyer
Study officials:
affiliation: Nantes University Hospital
name: Jean-Baptiste Ducloyer, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Yann Maucourant, M.D
role: PRINCIPAL_INVESTIGATOR
References: