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

NCT06271330 | Recruiting

• 1 other identifier: AP_JBD_FarWest_004
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

  number of week

  1 year

Secondary Outcomes (1)

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

  1 year

Interventions

Faricimab DRUG

switch from previous anti-VEGF agents to faricimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Rennes University Hospital: collaborator

Study Sites (1)

Ducloyer

Nantes, 44000, France

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

faricimab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jean-Baptiste Ducloyer, M.D

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Yann Maucourant, M.D

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Baptiste Ducloyer, M.D

CONTACT

02 40 08 34 01; jeanbaptiste.ducloyer@chu-nantes.fr

Alexandra Poinas, PhD

CONTACT

0253482857; alexandra.poinas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)