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Neovascular Age-Related Macular Degeneration (nAMD)NCT06890026

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

An observational study of Neovascular Age-Related Macular Degeneration (nAMD) and Treatment-naïve, 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
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Faricimab Injection [Vabysmo]
Type of treatment
Injection or infusion
How many people
742 participants
Where
1 siteDenmark
Study dates
15 Nov 2024to 1 Mar 2026
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients from the Capital Region of Denmark.

Who may be able to join

  • 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.

Who cannot join

  • 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.

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: Durability of Three Monthly Loading Doses With Faricimab Injections in Patients With 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),

Being tested
Faricimab Injection [Vabysmo]
Keywords
Neovascular Age-related Macular Degeneration, anti-VEGF, faricimab, loading dose

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 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.

What is being measured

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

  1. Durability of the loadings dose with 3 faricimab injections

    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).

    Measured: 01/NOV/2023 - 28/FEB/2025

Secondary outcomes (2)

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

    Described in survival probabilities and 95% CI

    Measured: 01/NOV/2023 - 28/FEB/2025

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

    Described in logMAR and ETRDS letters

    Measured: 01/NOV/2023 - 28/FEB/2025

Timeline

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

  1. First posted21 Mar 2025
  2. Study start15 Nov 2024
  3. Primary completion1 Mar 2026
  4. Study completion1 Mar 2026

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
742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06890026
Sponsor's protocol ID
p-2024-16973
Status last verified
Mar 2026
First submitted
16 Mar 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Freund KB, Mrejen S, Gallego-Pinazo R. An update on the pharmacotherapy of neovascular age-related macular degeneration. Expert Opin Pharmacother. 2013 Jun;14(8):1017-28. doi: 10.1517/14656566.2013.787410. Epub 2013 Apr 8.

    PubMed 23560774

  • Li JQ, Welchowski T, Schmid M, Mauschitz MM, Holz FG, Finger RP. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis. Br J Ophthalmol. 2020 Aug;104(8):1077-1084. doi: 10.1136/bjophthalmol-2019-314422. Epub 2019 Nov 11.

    PubMed 31712255

  • Turan L, Bjerager J, Subhi Y, Klefter ON, Hajari JN, Schneider M. Durability of Three Monthly Loading Doses with Faricimab in Treatment-Naive Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2026 Jun;15(6):2051-2061. doi: 10.1007/s40123-026-01396-z. Epub 2026 May 9.

    PubMed 42105126

Questions about this trial

What is this clinical trial studying?

An observational study of Neovascular Age-Related Macular Degeneration (nAMD) and Treatment-naïve, 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 5 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 27 Mar 2026. 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?

Durability of the loadings dose with 3 faricimab injections (time frame: 01/NOV/2023 - 28/FEB/2025). 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 NCT06890026, which also lists 4 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 27 Mar 2026.

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