Age-Related Macular Degeneration (ARMD) Clinical Trials

Find Age-Related Macular Degeneration (ARMD) Clinical Trials Near You

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A Multicenter Real-life Observational Retrospective Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With Refractory or Dependent Exudative AMD

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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.

Locations
Other Locations
France
Ducloyer
RECRUITING
Nantes
Contact Information
Primary
Jean-Baptiste Ducloyer, M.D
jeanbaptiste.ducloyer@chu-nantes.fr
02 40 08 34 01
Backup
Alexandra Poinas, PhD
alexandra.poinas@chu-nantes.fr
0253482857
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 100
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Nantes University Hospital
Collaborators: Rennes University Hospital

This content was sourced from clinicaltrials.gov

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