Clinical trial NCT06902207: Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy
Official title: Real-life Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Inflammation
Keywords: faricimab
intravitreal injection
anti-VEGF
intraocular inflammation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 6053
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the Capital Region of Denmark who are receiving faricimab injections at our center.

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Incidence of intraocular inflammation (IOI)
timeFrame: 01/NOV/2023 - 31/AUG/2024
Secondary outcomes:
measure: Differences in age
timeFrame: 01/NOV/2023 - 31/AUG/2024
measure: Differences in sex
timeFrame: 01/NOV/2023 - 31/AUG/2024
measure: Differences in number of anti-VEGF injections
timeFrame: 01/NOV/2023 - 31/AUG/2024
measure: Differences between treatment-naïve and switch-patients
timeFrame: 01/NOV/2023 - 31/AUG/2024
measure: Time from injection to onset of IOI
timeFrame: 01/NOV/2023 - 31/AUG/2024
measure: Disease duration of IOI
timeFrame: 01/NOV/2023 - 31/AUG/2024
measure: Functional outcome of IOI cases
timeFrame: 01/NOV/2023 - 31/AUG/2024
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Rigshospitalet
Study officials:
References:
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citation: European Medicines Agency (2022) Vabysmo. https://www.ema.europa.eu/en/medicines/human/EPAR/vabysmo Accessed: 07 Sep 2023
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: 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.