AzTrials
AzTrials

Intraocular InflammationNCT06902207

Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

An observational study of Intraocular Inflammation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intraocular Inflammation
What is being tested?
Faricimab Injection [Vabysmo]
Type of treatment
Injection or infusion
How many people
6,053 participants
Where
1 siteDenmark
Study dates
10 Nov 2024to 1 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients in the Capital Region of Denmark who are receiving faricimab injections at our center.

Who may be able to join

  • >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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Ophthalmology, Rigshospitalet

    Glostrup Municipality, 2600

Other trials in Denmark

About this study

Official title: Real-life 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.

Read more

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.

Being tested
Faricimab Injection [Vabysmo]
Keywords
faricimab, intravitreal injection, anti-VEGF, intraocular inflammation
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Faricimab Injection [Vabysmo]Drug

    Also called Intravitreal injection

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of intraocular inflammation (IOI)

    Incidence of IOI following the faricimab injection procedure, described as cases per eye, cases per patient and cases per injection

    Measured: 01/NOV/2023 - 31/AUG/2024

Secondary outcomes (7)

  1. Differences in age

    Between individuals developing and not developing IOI following faricimab injection

    Measured: 01/NOV/2023 - 31/AUG/2024

  2. Differences in sex

    Between individuals developing and not developing IOI following faricimab injection

    Measured: 01/NOV/2023 - 31/AUG/2024

  3. Differences in number of anti-VEGF injections

    Between individuals developing and not developing IOI following faricimab injection

    Measured: 01/NOV/2023 - 31/AUG/2024

  4. Differences between treatment-naïve and switch-patients

    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.

    Measured: 01/NOV/2023 - 31/AUG/2024

  5. Time from injection to onset of IOI

    Measured in days

    Measured: 01/NOV/2023 - 31/AUG/2024

  6. Disease duration of IOI

    Measured in days

    Measured: 01/NOV/2023 - 31/AUG/2024

  7. Functional outcome of IOI cases

    Best-corrected visual acuity (BCVA) before, at, and after onset of the IOI. Measured in Snellen acuity, converted to logMAR.

    Measured: 01/NOV/2023 - 31/AUG/2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start10 Nov 2024
  3. Primary completion26 Jan 2025
  4. Study completion1 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
6,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06902207
Sponsor's protocol ID
p-2024-16902
Status last verified
Mar 2025
First submitted
15 Mar 2025
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.

    PubMed 16196117

  • Anderson WJ, da Cruz NFS, Lima LH, Emerson GG, Rodrigues EB, Melo GB. Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review. Int J Retina Vitreous. 2021 May 7;7(1):37. doi: 10.1186/s40942-021-00307-7.

    PubMed 33962696

  • Fine HF, Despotidis GD, Prenner JL. Ocular inflammation associated with antivascular endothelial growth factor treatment. Curr Opin Ophthalmol. 2015 May;26(3):184-7. doi: 10.1097/ICU.0000000000000154.

    PubMed 25822254

  • Shirley M. Faricimab: First Approval. Drugs. 2022 May;82(7):825-830. doi: 10.1007/s40265-022-01713-3.

    PubMed 35474059

  • European Medicines Agency (2022) Vabysmo. https://www.ema.europa.eu/en/medicines/human/EPAR/vabysmo Accessed: 07 Sep 2023

  • Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.

    PubMed 35085502

  • Khanani AM, Patel SS, Ferrone PJ, Osborne A, Sahni J, Grzeschik S, Basu K, Ehrlich JS, Haskova Z, Dugel PU. Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):964-972. doi: 10.1001/jamaophthalmol.2020.2699.

    PubMed 32729897

  • Schneider M, Turan L, Arif F, Bjerager J, Klefter ON, Faber C, Subhi Y, Hajari JN. Real-world incidence and clinical characteristics of intraocular inflammation following intravitreal faricimab therapy: A safety study. Acta Ophthalmol. 2026 May 16. doi: 10.1111/aos.70161. Online ahead of print.

    PubMed 42141825

Questions about this trial

What is this clinical trial studying?

An observational study of Intraocular Inflammation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intraocular inflammation (IOI) (time frame: 01/NOV/2023 - 31/AUG/2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06902207, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in