Retina (Philadelphia, Pa.) · 2025
IMPACT OF FARICIMAB VERSUS AFLIBERCEPT ON EPIRETINAL MEMBRANE FORMATION OVER 2 YEARS IN PATIENTS WITH DIABETIC MACULAR EDEMA IN THE PHASE 3 YOSEMITE AND RHINE TRIALS.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Jaffe Glenn J, Deák Gábor, Gibson Kara, Khurana Rahul N, Nudleman Eric, Ogura Yuichiro, Schmidt-Erfurth Ursula, Wang Tracey, Westenskow Peter D, Wong David, Yiu Glenn, Willis Jeffrey R
Аннотация
BACKGROUND/PURPOSE: To assess the effects of faricimab versus aflibercept on epiretinal membrane (ERM) formation in eyes with diabetic macular edema.
METHODS: Post hoc analysis of phase 3 YOSEMITE/RHINE trial data in eyes with diabetic macular edema receiving faricimab every 8 weeks (Q8W), faricimab treat-and-extend (T&E; up to Q16W depending on central subfield thickness and best-corrected visual acuity), or aflibercept Q8W for 100 weeks.
RESULTS: ERMs developed in 3.8% (23/602) of eyes treated with faricimab Q8W, 5.1% (31/608) with faricimab T&E, and 7.6% (45/590) with aflibercept Q8W at 100 weeks. ERMs were less likely with faricimab Q8W versus aflibercept Q8W (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.29-0.81, P = 0.0055). The mean (SD) best-corrected visual acuity at 100 weeks in eyes with and without ERMs were 69.2 (13.6) letters [20/40 Snellen] versus 73.8 (13.1) [20/40 Snellen], respectively; the mean (SD) CSTs were 315.8 (99.2) versus 274.6 (74.1) µ m. Faricimab T&E dosing intervals were extended ≥ Q12W in 79.7% of eyes without ERMs versus 50.0% with ERMs.
CONCLUSION: Risk of ERMs was 52% lower with faricimab Q8W versus aflibercept Q8W over 100 weeks in eyes with diabetic macular edema, suggesting a potential role for faricimab in reducing pre-retinal fibrotic proliferation. The results may help inform physician/patient decision-making when initiating intravitreal therapy.
TRIAL REGISTRATION: NCT03622580 and NCT03622593.
METHODS: Post hoc analysis of phase 3 YOSEMITE/RHINE trial data in eyes with diabetic macular edema receiving faricimab every 8 weeks (Q8W), faricimab treat-and-extend (T&E; up to Q16W depending on central subfield thickness and best-corrected visual acuity), or aflibercept Q8W for 100 weeks.
RESULTS: ERMs developed in 3.8% (23/602) of eyes treated with faricimab Q8W, 5.1% (31/608) with faricimab T&E, and 7.6% (45/590) with aflibercept Q8W at 100 weeks. ERMs were less likely with faricimab Q8W versus aflibercept Q8W (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.29-0.81, P = 0.0055). The mean (SD) best-corrected visual acuity at 100 weeks in eyes with and without ERMs were 69.2 (13.6) letters [20/40 Snellen] versus 73.8 (13.1) [20/40 Snellen], respectively; the mean (SD) CSTs were 315.8 (99.2) versus 274.6 (74.1) µ m. Faricimab T&E dosing intervals were extended ≥ Q12W in 79.7% of eyes without ERMs versus 50.0% with ERMs.
CONCLUSION: Risk of ERMs was 52% lower with faricimab Q8W versus aflibercept Q8W over 100 weeks in eyes with diabetic macular edema, suggesting a potential role for faricimab in reducing pre-retinal fibrotic proliferation. The results may help inform physician/patient decision-making when initiating intravitreal therapy.
TRIAL REGISTRATION: NCT03622580 and NCT03622593.
Предметные рубрики MeSH
HumansMacular EdemaReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsDiabetic RetinopathyVisual AcuityFemaleIntravitreal InjectionsMaleTomography, Optical CoherenceEpiretinal MembraneAgedMiddle AgedAngiogenesis InhibitorsFollow-Up StudiesTime FactorsVascular Endothelial Growth Factor ATreatment OutcomeDouble-Blind MethodMacula LuteaAntibodies, Bispecific