Neovascular Age-Related Macular Degeneration (nAMD), Treatment-naïve
Conditions
Keywords
Neovascular Age-related Macular Degeneration, anti-VEGF, faricimab, loading dose
Brief 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),
Interventions
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.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durability of the loadings dose with 3 faricimab injections | 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
| Measure | Time frame | Description |
|---|---|---|
| Injection-free survival probabilities at prespecified time points (4-24 weeks post-loading in 2-weekly increments) | 01/NOV/2023 - 28/FEB/2025 | Described in survival probabilities and 95% CI |
| Change in best-corrected visual acuity (BCVA) following the loading phase with faricimab at 4 weeks. | 01/NOV/2023 - 28/FEB/2025 | Described in logMAR and ETRDS letters |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORMiklos Schneider, MD, PhD
Glostrup University Hospital, Copenhagen
Outcome results
None listed