Department of Ophthalmology, Rigshospitalet
Glostrup Municipality, 2600, Denmark
NCT Number: NCT06902207
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.
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Notify Me18 year and older
All sexes
Observational
Glostrup Municipality, 2600, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
for IOI cases
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.
Other names: Intravitreal injection
Time frame: 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
Time frame: 01/NOV/2023 - 31/AUG/2024
Between individuals developing and not developing IOI following faricimab injection
Time frame: 01/NOV/2023 - 31/AUG/2024
Between individuals developing and not developing IOI following faricimab injection
Time frame: 01/NOV/2023 - 31/AUG/2024
Between individuals developing and not developing IOI following faricimab injection
Time frame: 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 frame: 01/NOV/2023 - 31/AUG/2024
Measured in days
Time frame: 01/NOV/2023 - 31/AUG/2024
Measured in days
Time frame: 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.
Rigshospitalet, Denmark
Other
Real-life Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy
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