Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

Completed

• Conditions: Intraocular Inflammation

• Registration Number: NCT06902207
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-10
• Primary Completion: 2025-01-26
• Status Verified: 2025-03
• Study Completion: 2025-03-01
• Study First Submitted: 2025-03-15
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6053

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ophthalmology, Rigshospitalet; 🇩🇰 Glostrup, Denmark