CompletedNot Applicable

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

Denmark742 participantsStarted 2024-11-15

Plain-language 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. 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),

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Durability of the loadings dose with 3 faricimab injections

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

Trial details

NCT IDNCT06890026

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Neovascular Age-Related Macular Degeneration (nAMD) trials