Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

Real-life Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

Faricimab (Vabysmo®), a novel pharmaceutical agent is a promising treatment for age-related macular degeneration and diabetic macular edema due to its dual mechanism of action, targeting both the VEGF and angiopoietin-2 (Ang-2) pathways, offering potential benefits in improving visual outcomes and reducing treatment burdens. The phase 3 TENAYA and LUCERNE clinical trials have demonstrated its efficacy and safety profile, leading to regulatory approval and increasing use in clinical practice. However, as with any new therapeutic agent, there is a critical need to monitor and evaluate real-world safety data to complement and validate clinical trial findings.

Intraocular inflammation (IOI), which is a significant adverse effect of intravitreal anti-VEGF injections, is of particular interest as it can vary from a mild transient reaction to a potentially vision-threatening outcome.

The incidence and severity of IOI in a real-world settings can vary from clinical trial results due to differences in patient populations, injection techniques, and clinical settings.

The aim of this study is to estimate the real-life incidence of intraocular inflammation following intravitreal faricimab injections at a large, regional highly specialized tertiary center.

Study Overview

• Status: Completed
• Conditions: Intraocular Inflammation
• Intervention / Treatment: Drug: Faricimab Injection [Vabysmo]

• Study Type: Observational
• Enrollment (Actual): 6053

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Department of Ophthalmology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in the Capital Region of Denmark who are receiving faricimab injections at our center.

Description

Inclusion criteria

• >18 years of age
• Having received at least 1 intravitreal faricimab injection at our center
• Follow-up period of at least 6 weeks after the injection

Exclusion criteria for IOI cases

• Having received intravitreal injections of other types (e.g., intravitreal steroids, antiviral agents) at the same time as the intravitreal anti-VEGF injection or during the follow-up period
• Underwent intraocular surgery within 6 weeks before or after the intravitreal injection, except for surgical interventions that are meant to diagnose or treat the actual IOI in question (e.g., diagnostic chamber tap, diagnostic vitrectomy, vitrectomy for suspected endophthalmitis, etc.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraocular inflammation (IOI)	Incidence of IOI following the faricimab injection procedure, described as cases per eye, cases per patient and cases per injection	01/NOV/2023 - 31/AUG/2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in age	Between individuals developing and not developing IOI following faricimab injection	01/NOV/2023 - 31/AUG/2024
Differences in sex	Between individuals developing and not developing IOI following faricimab injection	01/NOV/2023 - 31/AUG/2024
Differences in number of anti-VEGF injections	Between individuals developing and not developing IOI following faricimab injection	01/NOV/2023 - 31/AUG/2024
Differences between treatment-naïve and switch-patients	Differences in developing and not developing IOI following faricimab injection between patients that received previous anti-VEGF treatments before faricimab and those that did not.	01/NOV/2023 - 31/AUG/2024
Time from injection to onset of IOI	Measured in days	01/NOV/2023 - 31/AUG/2024
Disease duration of IOI	Measured in days	01/NOV/2023 - 31/AUG/2024
Functional outcome of IOI cases	Best-corrected visual acuity (BCVA) before, at, and after onset of the IOI. Measured in Snellen acuity, converted to logMAR.	01/NOV/2023 - 31/AUG/2024

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Publications and helpful links

General Publications

• Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
• 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.
• Anderson WJ, da Cruz NFS, Lima LH, Emerson GG, Rodrigues EB, Melo GB. Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review. Int J Retina Vitreous. 2021 May 7;7(1):37. doi: 10.1186/s40942-021-00307-7.
• Fine HF, Despotidis GD, Prenner JL. Ocular inflammation associated with antivascular endothelial growth factor treatment. Curr Opin Ophthalmol. 2015 May;26(3):184-7. doi: 10.1097/ICU.0000000000000154.
• Shirley M. Faricimab: First Approval. Drugs. 2022 May;82(7):825-830. doi: 10.1007/s40265-022-01713-3.
• European Medicines Agency (2022) Vabysmo. https://www.ema.europa.eu/en/medicines/human/EPAR/vabysmo Accessed: 07 Sep 2023
• Khanani AM, Patel SS, Ferrone PJ, Osborne A, Sahni J, Grzeschik S, Basu K, Ehrlich JS, Haskova Z, Dugel PU. Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):964-972. doi: 10.1001/jamaophthalmol.2020.2699. Erratum In: JAMA Ophthalmol. 2020 Sep 1;138(9):1006. doi: 10.1001/jamaophthalmol.2020.3537.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Actual): January 26, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 15, 2025
• First Submitted That Met QC Criteria: March 23, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: intravitreal injection; anti-VEGF; faricimab; intraocular inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Inflammation; Uveitis; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Faricimab
• Other Study ID Numbers: p-2024-16902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No