Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

NCT06902207 | Completed FDA Drug

• 1 other identifier: p-2024-16902
• Study Type: observational
• Target: 6,053
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraocular Inflammation

Keywords

faricimab; intravitreal injection; anti-VEGF; intraocular inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Differences in age

  01/NOV/2023 - 31/AUG/2024

• Differences in sex

  01/NOV/2023 - 31/AUG/2024

• Differences in number of anti-VEGF injections

  01/NOV/2023 - 31/AUG/2024

• Differences between treatment-naïve and switch-patients

  01/NOV/2023 - 31/AUG/2024

• Time from injection to onset of IOI

  01/NOV/2023 - 31/AUG/2024

Interventions

Faricimab Injection [Vabysmo] DRUG

The procedures followed local standard protocol, that included the use of 2-3 drops of topical tetracaine anesthesia, use of an eye speculum, topical 5% povidone-iodine disinfection, 33G-needle, injection site 3.5 mm posterior from the limbus marked by calipers in the supertemporal or the inferotemporal quadrant, sterile cotton tip tamponade at the site of injection after removal of the needle, and no post-procedure antibiotics.

Also known as: Intravitreal injection

Eligibility Criteria

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

Study Population

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

You may qualify if:

• \>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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Ophthalmology, Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location

Related Publications (7)

• 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.

  PMID: 16196117 BACKGROUND

• 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.

  PMID: 33962696 BACKGROUND

• 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.

  PMID: 25822254 BACKGROUND

• Shirley M. Faricimab: First Approval. Drugs. 2022 May;82(7):825-830. doi: 10.1007/s40265-022-01713-3.

  PMID: 35474059 BACKGROUND

• European Medicines Agency (2022) Vabysmo. https://www.ema.europa.eu/en/medicines/human/EPAR/vabysmo Accessed: 07 Sep 2023

  BACKGROUND

• 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

• 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.

  PMID: 32729897 BACKGROUND

MeSH Terms

Conditions

Uveitis

Interventions

faricimab; Intravitreal Injections

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

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 15, 2025
• First Posted: March 30, 2025
• Study Start: November 10, 2024
• Primary Completion: January 26, 2025
• Study Completion: March 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)