Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Faricimab

    Drug

    switch from previous anti-VEGF agents to faricimab

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment.

number of week

Time frame
1 year

Secondary outcomes

1

Difference between time to recurrence before switch and after switch.

time to recurrence in weeks

Time frame
1 year

Other outcomes

Sponsors and contacts

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Nantes University Hospital

Lead sponsor

Rennes University Hospital

Collaborator