Actively Recruiting

Age: 18Years +
All Genders
NCT06271330

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

Led by Nantes University Hospital · Updated on 2025-01-16

100

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

N

Nantes University Hospital

Lead Sponsor

R

Rennes University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patient of legal age (≥18 years) with exudative AMD treated with IVT ranibizumab or aflibercept for more than 1 year
  • Patient whose IVT injection interval is strictly less than 12 weeks
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ducloyer

Nantes, France, 44000

Actively Recruiting

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Research Team

J

Jean-Baptiste Ducloyer, M.D

CONTACT

A

Alexandra Poinas, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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