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NCT Number: NCT06271330

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faricimab

Drug

switch from previous anti-VEGF agents to faricimab

Primary outcomes

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

    Time frame: 1 year

    number of week

Secondary outcomes

  1. Difference between time to recurrence before switch and after switch.

    Time frame: 1 year

    time to recurrence in weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Poinas, PhD

CONTACT

[email protected]

0253482857

Jean-Baptiste Ducloyer, M.D

CONTACT

[email protected]

02 40 08 34 01

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Rennes University Hospital

Registry information

Official study title

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

Acronym: FAR-WEST

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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