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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),
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab Injection [Vabysmo] | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 01/NOV/2023 - 28/FEB/2025 |
| Measure | Description | Time Frame |
|---|---|---|
| Injection-free survival probabilities at prespecified time points (4-24 weeks post-loading in 2-weekly increments) | 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. |
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Inclusion criteria
Exclusion criteria
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Patients from the Capital Region of Denmark.
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| Name | Affiliation | Role |
|---|---|---|
| Miklos Schneider, MD, PhD | Glostrup University Hospital, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Rigshospitalet | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35085502 | Background | 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. | |
| 23560774 |
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Described in logMAR and ETRDS letters |
| 01/NOV/2023 - 28/FEB/2025 |
| Background |
| 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. |
| 31712255 | Background | 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. |
| 42105126 | Derived | 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. |
| ID | Term |
|---|---|
| C000723200 | faricimab |
| D058449 | Intravitreal Injections |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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