Intraocular Inflammation
Conditions
Keywords
faricimab, intravitreal injection, anti-VEGF, intraocular inflammation
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.
Interventions
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.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Differences in age | 01/NOV/2023 - 31/AUG/2024 | Between individuals developing and not developing IOI following faricimab injection |
| 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. |
| Time from injection to onset of IOI | 01/NOV/2023 - 31/AUG/2024 | Measured in days |
Countries
Denmark
Outcome results
None listed