Department of Ophthalmology, Rigshospitalet
Glostrup Municipality, 2600, Denmark
NCT Number: NCT06890026
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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Notify Me50 year and older
All sexes
Observational
Glostrup Municipality, 2600, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Intravitreal injection
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).
Time frame: 01/NOV/2023 - 28/FEB/2025
Described in survival probabilities and 95% CI
Time frame: 01/NOV/2023 - 28/FEB/2025
Described in logMAR and ETRDS letters
Rigshospitalet, Denmark
Other
Durability of Three Monthly Loading Doses With Faricimab Injections in Patients With Treatment-naïve Neovascular Age-related Macular Degeneration
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