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OpenTrials
Completed

NCT Number: NCT06902207

Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Rigshospitalet

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Faricimab Injection [Vabysmo]

Drug

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

Primary outcomes

  1. Incidence of intraocular inflammation (IOI)

    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

Secondary outcomes

  1. Differences in age

    Time frame: 01/NOV/2023 - 31/AUG/2024

    Between individuals developing and not developing IOI following faricimab injection

  2. Differences in sex

    Time frame: 01/NOV/2023 - 31/AUG/2024

    Between individuals developing and not developing IOI following faricimab injection

  3. Differences in number of anti-VEGF injections

    Time frame: 01/NOV/2023 - 31/AUG/2024

    Between individuals developing and not developing IOI following faricimab injection

  4. Differences between treatment-naïve and switch-patients

    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.

  5. Time from injection to onset of IOI

    Time frame: 01/NOV/2023 - 31/AUG/2024

    Measured in days

  6. Disease duration of IOI

    Time frame: 01/NOV/2023 - 31/AUG/2024

    Measured in days

  7. Functional outcome of IOI cases

    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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Real-life Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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