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

NCT06890026 | Completed FDA Drug

• 1 other identifier: p-2024-16973
• Study Type: observational
• Target: 742
• Locations: 1 country
• Sites: 1

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),

Conditions

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

Keywords

Neovascular Age-related Macular Degeneration; anti-VEGF; faricimab; loading dose

Outcome Measures

Primary Outcomes (1)

• Durability of the loadings dose with 3 faricimab injections

  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).

  01/NOV/2023 - 28/FEB/2025

Secondary Outcomes (2)

• Injection-free survival probabilities at prespecified time points (4-24 weeks post-loading in 2-weekly increments)

  01/NOV/2023 - 28/FEB/2025

• Change in best-corrected visual acuity (BCVA) following the loading phase with faricimab at 4 weeks.

  01/NOV/2023 - 28/FEB/2025

Interventions

Faricimab Injection [Vabysmo] DRUG

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.

Also known as: Intravitreal injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the Capital Region of Denmark.

You may qualify if:

• Age of 50 years or older.
• Treatment-naïve patients diagnosed with nAMD who have received a loading dose with intravitreal faricimab between November 1, 2023, and August 31, 2024.
• 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 180 days.

You may not qualify if:

• 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.
• Poor baseline BCVA defined as \<0.1 Snellen (\>1.0 logMAR)
• Deviation of ± 2 weeks from the planned loading dose interval of 4 weeks.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Ophthalmology, Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location

Related Publications (3)

• 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.

  PMID: 35085502 BACKGROUND

• 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.

  PMID: 23560774 BACKGROUND

• 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.

  PMID: 31712255 BACKGROUND

MeSH Terms

Interventions

faricimab; Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Miklos Schneider, MD, PhD

  Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 21, 2025
• Study Start: November 15, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)