Ophthalmology. Retina · 2026
Faricimab for High-Need Aflibercept 2 mg-Treated Neovascular Age-Related Macular Degeneration: A Randomized Comparator-Controlled Trial.
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Michelitsch Monja, Riedl Regina, Strini Sanja, Posch-Pertl Laura, Wallisch Fabian, Djavid Daniel, Haas Anton, Wedrich Andreas, Weger Martin
Аннотация
PURPOSE: To assess whether "high-need" treated neovascular age-related macular degeneration (nAMD) eyes, requiring aflibercept 2 mg every 3 to 5 weeks, can be extended in their treatment interval when switched to faricimab.
DESIGN: A monocenter, randomized, double-masked, 2-part clinical trial (NCT05941715) with a comparator-controlled period of 32 weeks, followed by a single-arm open-label treatment period of up to 56 weeks.
PARTICIPANTS: Patients with nAMD treated with aflibercept 2 mg, exhibiting retinal fluid at ≤6-week treatment intervals within a treat-and-extend (T&E) regimen, were recruited at the Medical University of Graz between July 2023 and January 2024.
METHODS: Seventy participants were randomized 1:1 to receive either faricimab T&E (comparator group, n = 35) or aflibercept 2 mg (control group, n = 35) T&E until week 32. From week 32 until week 56, both groups received faricimab T&E. Treatment intervals, change in central subfield thickness (CST), and visual acuity were assessed.
MAIN OUTCOME MEASURE: The proportion of eyes with at least 1 successful extension, meaning no retinal fluid at a 6-week treatment interval, up to ≤32 weeks.
RESULTS: In the comparator-controlled period, 12 (34.3%) faricimab-treated eyes versus 3 (8.6%) aflibercept 2 mg-treated eyes were successfully extended by ≥2 weeks (P = 0.018). At 56 weeks, after both groups were treated with faricimab, 14 (40%) and 13 (37.1%) eyes, respectively, were successfully extended. Least square mean difference (LSMD) CST significantly reduced in the comparator group from baseline to 32 weeks by -36.4 μm (95% confidence interval [CI], -56.0 to -16.8; P < 0.001) and to 56 weeks by -43.7 μm (95% CI, -64.3 to -23.2; P < 0.001). In the control group, LSMD CST remained stable from baseline to 32 weeks with +2.7 μm (95% CI, -17.5 to 22.8; P = 0.793); when switched to faricimab, it significantly reduced at 56 weeks by -47.0 μm (95% CI, -67.7 to -26.4; P < 0.001). Visual acuity remained stable for both groups.
CONCLUSIONS: In this first randomized clinical trial comparing faricimab with aflibercept 2 mg in "high-need" aflibercept 2 mg-treated nAMD eyes, switching to faricimab was effective in extending treatment intervals in more than a third of eyes.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
DESIGN: A monocenter, randomized, double-masked, 2-part clinical trial (NCT05941715) with a comparator-controlled period of 32 weeks, followed by a single-arm open-label treatment period of up to 56 weeks.
PARTICIPANTS: Patients with nAMD treated with aflibercept 2 mg, exhibiting retinal fluid at ≤6-week treatment intervals within a treat-and-extend (T&E) regimen, were recruited at the Medical University of Graz between July 2023 and January 2024.
METHODS: Seventy participants were randomized 1:1 to receive either faricimab T&E (comparator group, n = 35) or aflibercept 2 mg (control group, n = 35) T&E until week 32. From week 32 until week 56, both groups received faricimab T&E. Treatment intervals, change in central subfield thickness (CST), and visual acuity were assessed.
MAIN OUTCOME MEASURE: The proportion of eyes with at least 1 successful extension, meaning no retinal fluid at a 6-week treatment interval, up to ≤32 weeks.
RESULTS: In the comparator-controlled period, 12 (34.3%) faricimab-treated eyes versus 3 (8.6%) aflibercept 2 mg-treated eyes were successfully extended by ≥2 weeks (P = 0.018). At 56 weeks, after both groups were treated with faricimab, 14 (40%) and 13 (37.1%) eyes, respectively, were successfully extended. Least square mean difference (LSMD) CST significantly reduced in the comparator group from baseline to 32 weeks by -36.4 μm (95% confidence interval [CI], -56.0 to -16.8; P < 0.001) and to 56 weeks by -43.7 μm (95% CI, -64.3 to -23.2; P < 0.001). In the control group, LSMD CST remained stable from baseline to 32 weeks with +2.7 μm (95% CI, -17.5 to 22.8; P = 0.793); when switched to faricimab, it significantly reduced at 56 weeks by -47.0 μm (95% CI, -67.7 to -26.4; P < 0.001). Visual acuity remained stable for both groups.
CONCLUSIONS: In this first randomized clinical trial comparing faricimab with aflibercept 2 mg in "high-need" aflibercept 2 mg-treated nAMD eyes, switching to faricimab was effective in extending treatment intervals in more than a third of eyes.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.