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

March 23, 2026 updated by: Miklos Schneider MD, PhD, Rigshospitalet, Denmark

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),

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

742

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup Municipality, Denmark, 2600
        • Department of Ophthalmology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from the Capital Region of Denmark.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
01/NOV/2023 - 28/FEB/2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
01/NOV/2023 - 28/FEB/2025
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
01/NOV/2023 - 28/FEB/2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Miklos Schneider, MD, PhD, Glostrup University Hospital, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

March 16, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p-2024-16973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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