NCT06890026

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 742 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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),

Conditions

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

Interventions

Type	Name	Description
DRUG	Faricimab Injection [Vabysmo]	The procedures were carried out according to the local standard protocol, which involved applying 2-3 drops of topical tetracaine anesthesia, using an eye speculum, disinfecting with 5% povidone-iodine, employing a 33G needle, marking the injection site 3.5 mm posterior to the limbus with calipers in either the superotemporal or inferotemporal quadrant, applying a sterile cotton tip for tamponade after needle removal, and omitting post-procedure antibiotics.

Timeline

• Start date: 2024-11-15
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-03-21
• Last updated: 2026-03-27

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study