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OpenTrials
Completed

NCT Number: NCT06890026

Durability of Three Monthly Loading Doses With Faricimab in Treatment-naïve Neovascular Age-related Macular Degeneration

Neovascular Age-Related Macular Degeneration (nAMD) is a one of the leading causes of irreversible vision loss among the elderly in developed countries. The implementation of anti-VEGF therapies in the last decades has significantly improved AMD management. Faricimab (Vabysmo®), a bispecific antibody targeting both Vascular Endothelial Growth Factor A (VEGF-A) and Angiopoietin-2 (Ang-2), offers enhanced disease control by both inhibiting angiogenesis and stabilizing blood vessels to prevent inflammation and leakage. Faricimab is thought to potentially reduce the frequency of injections compared to therapies targeting only VEGF-A. A key aspect of evaluating its efficacy is understanding the interval before the need for subsequent injections following the initial loading dose. Treatment with intravitreal anti-VEGF injections would typically start with three injections administered at four-weekly intervals, however faricimab is recommended to be started with four loading injections. Our department routinely initiates anti-VEGF therapy with 3 loading doses and then follows an observe-and-plan regimen. This routine was continued with faricimab injections as well despite the manufacturer's recommendation of 4 monthly loading doses.

Determining the optimal interval for reinjection is crucial for reducing treatment burden and improving patient quality of life.

This study aims to assess the durability of a loading dose of 3 faricimab injections, the need for a follow-up checkup at 4 weeks post-loading and functional outcomes post-loading in treatment-naive patients with neovascular age-related macular degeneration (nAMD),

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Key information

Age range

50 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

  • Age of 50 years or older.
  • Treatment-naïve patients diagnosed with nAMD who have received a loading dose with intravitreal faricimab between November 1, 2023, and August 31, 2024.
  • Follow-up data available until the next subsequent faricimab injection after the loading dose, OR if no injections were indicated following the loading dose, follow-up data for at least 180 days.

Exclusion criteria

  • History of previous anti-VEGF treatment.
  • Neovascular conditions other than AMD (e.g., choroidal neovascularization due to other causes) or co-existence of other retinal disease in the study eye.
  • Intraocular surgery in the study eye during the loading dose or prior to the first follow-up visit after the loading dose.
  • Poor baseline BCVA defined as <0.1 Snellen (>1.0 logMAR)
  • Deviation of ± 2 weeks from the planned loading dose interval of 4 weeks.

Treatment and study plan

Faricimab Injection [Vabysmo]

Drug

The procedures were carried out according to the local standard protocol, which involved applying 2-3 drops of topical tetracaine anesthesia, using an eye speculum, disinfecting with 5% povidone-iodine, employing a 33G needle, marking the injection site 3.5 mm posterior to the limbus with calipers in either the superotemporal or inferotemporal quadrant, applying a sterile cotton tip for tamponade after needle removal, and omitting post-procedure antibiotics.

Other names: Intravitreal injection

Primary outcomes

  1. Durability of the loadings dose with 3 faricimab injections

    Time frame: 01/NOV/2023 - 28/FEB/2025

    Defined as the time from the third injection in the loading dose series to the next required faricimab injection among those needing reinjection (in weeks).

Secondary outcomes

  1. Injection-free survival probabilities at prespecified time points (4-24 weeks post-loading in 2-weekly increments)

    Time frame: 01/NOV/2023 - 28/FEB/2025

    Described in survival probabilities and 95% CI

  2. Change in best-corrected visual acuity (BCVA) following the loading phase with faricimab at 4 weeks.

    Time frame: 01/NOV/2023 - 28/FEB/2025

    Described in logMAR and ETRDS letters

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Durability of Three Monthly Loading Doses With Faricimab Injections in Patients With Treatment-naïve Neovascular Age-related Macular Degeneration

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 27, 2026

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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