Clinical trial NCT06890026: Durability of Three Monthly Loading Doses With Faricimab in Treatment-naïve Neovascular Age-related Macular Degeneration
Official title: Durability of Three Monthly Loading Doses With Faricimab Injections in Patients With Treatment-naïve Neovascular Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neovascular Age-Related Macular Degeneration (nAMD)
Treatment-naïve
Keywords: Neovascular Age-related Macular Degeneration
anti-VEGF
faricimab
loading dose
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 833
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Capital Region of 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),


Eligibility criteria: Inclusion criteria

* Age of 50 years or older
* Treatment-naïve patients diagnosed with nAMD who have received a loading dose with intravitreal faricimab
* Follow-up data available until the next subsequent faricimab injection after the loading dose, OR if no injections were indicated following the loading dose, follow-up data for at least 4 months

Exclusion criteria

* History of previous anti-VEGF treatment.
* Neovascular conditions other than AMD (e.g., choroidal neovascularization due to other causes) or co-existence of other retinal disease in the study eye
* Intraocular surgery in the study eye during the loading dose or prior to the first follow-up visit after the loading dose.

Primary outcomes:
measure: Durability of the loadings dose with 3 faricimab injections
timeFrame: 01/NOV/2023 - 31/AUG/2024
Secondary outcomes:
measure: Proportion of patients with no need for a new injection at the first post-loading dose follow-up visit at 4 weeks.
timeFrame: 01/NOV/2023 - 31/AUG/2024
measure: Change in best-corrected visual acuity (BCVA) following the loading phase with faricimab at 4 weeks.
timeFrame: 01/NOV/2023 - 31/AUG/2024
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet Glostrup
name: Miklos Schneider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.
citation: Freund KB, Mrejen S, Gallego-Pinazo R. An update on the pharmacotherapy of neovascular age-related macular degeneration. Expert Opin Pharmacother. 2013 Jun;14(8):1017-28. doi: 10.1517/14656566.2013.787410. Epub 2013 Apr 8.
citation: Li JQ, Welchowski T, Schmid M, Mauschitz MM, Holz FG, Finger RP. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis. Br J Ophthalmol. 2020 Aug;104(8):1077-1084. doi: 10.1136/bjophthalmol-2019-314422. Epub 2019 Nov 11.