NCT06902207

Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

Real-life Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,053 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Faricimab Injection [Vabysmo]	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.

Timeline

• Start date: 2024-11-10
• Primary completion: 2025-01-26
• Completion: 2025-03-01
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study