NCT06890026Completed
Durability of Three Monthly Loading Doses With Faricimab in Treatment-naïve Neovascular Age-related Macular Degeneration
Durability of Three Monthly Loading Doses With Faricimab Injections in Patients With Treatment-naïve Neovascular Age-related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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),
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 742 (actual)
- First submitted
- 16 Mar 2025
- Start date
- 15 Nov 2024
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Macular degeneration
- NCT number
- NCT06890026
What you commit to
- Study type: Observational
- Participants enrolled: 742
- From 15 Nov 2024 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous anti-VEGF treatment.
- Intraocular surgery in the study eye during the loading dose or prior to the first follow-up visit after the loading dose.
Other illness
- Neovascular conditions other than AMD (e.g., choroidal neovascularization due to other causes) or co-existence of other retinal disease in the study eye.
Other
- Poor baseline BCVA defined as \<0.1 Snellen (\>1.0 logMAR)
- Deviation of ± 2 weeks from the planned loading dose interval of 4 weeks.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Ophthalmology, Rigshospitalet Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
Related publications
- Durability of Three Monthly Loading Doses with Faricimab in Treatment-Naïve Neovascular Age-Related Macular Degeneration.Ophthalmol Ther · 2026 · PMID 42105126
This page is information, not medical advice. Discuss any trial with your doctor.