Purpose: To assess the 12 month outcomes of intravitreal faricimab (IVF) in treatment-resistant diabetic macular edema (DME) recalcitrant to intravitreal aflibercept (IVA).
Methods: This study was undertaken as a retrospective interventional case series of DME subjects receiving care at a single private practice facility. Subjects at baseline had undergone ≥8 IVA injections over the previous 12 months, ≥4 IVA injections over the previous 6 months, had an optical coherence tomography (OCT)-measured central macular thickness (CMT) of ≥320 microns, and had observable edema on OCT. The baseline visit for this study's purpose was considered the examination in which the subject was changed from IVA to IVF. Subjects were managed with a treat-and-extend (TAE) protocol and followed over 12 months from baseline.
Results: A total of 51 eyes of 51 subjects were analyzed. There were 39.2% (20/51) of patients who reached a treatment interval of ≥8 weeks and had a fluid-free macula on OCT at 12 months. The CMT on OCT of the patient population reduced from 400.2 (385.3-415.3) microns at baseline to 340.6 (324.3-356.9) microns at 12 months (p<0.01). There were 21.6% (11/51) of patients who improved ≥3 lines of Snellen visual acuity at 12 months. The visual acuity of the overall study population improved from 0.60 (0.54-0.66) logMAR (Snellen 20/80) at baseline to 0.47 (0.41-0.53) logMAR (Snellen 20/59) at 12 months (p<0.01).
Conclusion: A longer treatment interval and improved functional and anatomical outcomes at 12 months may be attained in a clinically significant minority of aflibercept-resistant DME patients after changing to IVF when a TAE protocol is employed. Specialists may consider IVF whenever resistance to IVA is experienced in this patient population.
Keywords: diabetic macular edema; faricimab; recalcitrance; treatment-resistant.
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