Durability of Three Monthly Loading Doses With Faricimab in Treatment-naïve Neovascular Age-related Macular Degeneration

Active, not recruiting

• Conditions: Neovascular Age-Related Macular Degeneration (nAMD); Treatment-naïve

• Registration Number: NCT06890026
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Neovascular Age-Related Macular Degeneration (nAMD) is a one of the leading causes of irreversible vision loss among the elderly in developed countries. The implementation of anti-VEGF therapies in the last decades has significantly improved AMD management. Faricimab (Vabysmo®), a bispecific antibody targeting both Vascular Endothelial Growth Factor A (VEGF-A) and Angiopoietin-2 (Ang-2), offers enhanced disease control by both inhibiting angiogenesis and stabilizing blood vessels to prevent inflammation and leakage. Faricimab is thought to potentially reduce the frequency of injections compared to therapies targeting only VEGF-A. A key aspect of evaluating its efficacy is understanding the interval before the need for subsequent injections following the initial loading dose. Treatment with intravitreal anti-VEGF injections would typically start with three injections administered at four-weekly intervals, however faricimab is recommended to be started with four loading injections. Our department routinely initiates anti-VEGF therapy with 3 loading doses and then follows an observe-and-plan regimen. This routine was continued with faricimab injections as well despite the manufacturer's recommendation of 4 monthly loading doses.

Determining the optimal interval for reinjection is crucial for reducing treatment burden and improving patient quality of life.

This study aims to assess the durability of a loading dose of 3 faricimab injections, the need for a follow-up checkup at 4 weeks post-loading and functional outcomes post-loading in treatment-naive patients with neovascular age-related macular degeneration (nAMD),

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-15
• Status Verified: 2025-03
• Primary Completion: 2025-03-09
• Study First Submitted: 2025-03-16
• Study First Submitted QC: 2025-03-16
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 833

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Durability of the loadings dose with 3 faricimab injections	01/NOV/2023 - 31/AUG/2024	Defined as the time from the third injection in the loading dose series to the next required faricimab injection among those needing reinjection (in weeks).

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with no need for a new injection at the first post-loading dose follow-up visit at 4 weeks.	01/NOV/2023 - 31/AUG/2024	Described in percentage
Change in best-corrected visual acuity (BCVA) following the loading phase with faricimab at 4 weeks.	01/NOV/2023 - 31/AUG/2024	Described in ETRDS letters

Trial Locations

Locations (1)

Department of Ophthalmology, Rigshospitalet; 🇩🇰 Glostrup, Denmark