Short-term outcomes of faricimab and aflibercept 8 mg in diabetic macular edema
Objective: To evaluate and compare the effectiveness and treatment burden of faricimab and aflibercept 8 mg in treatment-naive patients with diabetic macular edema (DME) using a pro re nata (PRN) protocol. Design: Retrospective, observational cohort study. Subjects: A total of 28 eyes from 18 treatm...
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Elsevier
2025-07-01
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2950253525000358 |
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| author | Carlo Maccauro Yanny Jimenez Perez Piergiorgio Neri Ibraheem El Ghrably Haytham I Salti Francesco Pichi |
| author_facet | Carlo Maccauro Yanny Jimenez Perez Piergiorgio Neri Ibraheem El Ghrably Haytham I Salti Francesco Pichi |
| author_sort | Carlo Maccauro |
| collection | DOAJ |
| description | Objective: To evaluate and compare the effectiveness and treatment burden of faricimab and aflibercept 8 mg in treatment-naive patients with diabetic macular edema (DME) using a pro re nata (PRN) protocol. Design: Retrospective, observational cohort study. Subjects: A total of 28 eyes from 18 treatment-naive patients diagnosed with DME were included. Fourteen eyes were treated with faricimab, and fourteen eyes were treated with aflibercept 8 mg. Patients were selected based on clinical and imaging criteria confirming the presence of center-involving DME requiring anti-vascular endothelial growth factor (VEGF) therapy. Methods: Patients received loading doses of either four monthly faricimab injections or three aflibercept 8 mg injections and were followed for a total of approximately 6 to 9 months, including both loading and PRN phases. Primary outcomes included changes in best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR), central retinal thickness (CRT) assessed via optical coherence tomography (OCT), and the number of injections required. Secondary outcomes included fluid resolution rates based on OCT findings. Statistical comparisons between groups were performed using independent two-sample t-tests, with a p-value <0.05 considered statistically significant. Main Outcome Measures: Changes in BCVA, CRT, injection frequency, and fluid resolution. Results: The mean BCVA change was -0.12 logMAR for faricimab and -0.10 logMAR for aflibercept 8 mg (p = 0.41). The reductions in CRT were 96.2 µm and 91.6 µm, respectively (p = 0.58). The injection burden was similar, with an average of 5.71 injections for faricimab and 5.14 for aflibercept 8 mg (p = 0.32). Fluid resolution rates did not differ significantly between groups. No serious adverse events were reported. Conclusions: Both faricimab and aflibercept 8 mg demonstrated significant improvements in BCVA and CRT. While the results suggest comparable efficacy and safety between the two treatments, this conclusion should be interpreted cautiously due to the study's limitations. Specifically, the relatively small sample size and short follow-up duration. These findings highlight the importance of individualized treatment considerations, such as cost, accessibility, and patient preference. Further prospective studies are needed to validate these results and assess long-term treatment durability across different regimens. |
| format | Article |
| id | doaj-art-8189c0260f494231b51a54a86d7dda66 |
| institution | DOAJ |
| issn | 2950-2535 |
| language | English |
| publishDate | 2025-07-01 |
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| spelling | doaj-art-8189c0260f494231b51a54a86d7dda662025-08-20T03:07:24ZengElsevierAJO International2950-25352025-07-012210013210.1016/j.ajoint.2025.100132Short-term outcomes of faricimab and aflibercept 8 mg in diabetic macular edemaCarlo Maccauro0Yanny Jimenez Perez1Piergiorgio Neri2Ibraheem El Ghrably3Haytham I Salti4Francesco Pichi5University of Rome “Tor Vergata” ItalyCleveland Clinic Abu Dhabi, Abu Dhabi, United Arab EmiratesCleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates; Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USACleveland Clinic Abu Dhabi, Abu Dhabi, United Arab EmiratesCleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates; Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USACleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates; Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA; Corresponding author at: Eye Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.Objective: To evaluate and compare the effectiveness and treatment burden of faricimab and aflibercept 8 mg in treatment-naive patients with diabetic macular edema (DME) using a pro re nata (PRN) protocol. Design: Retrospective, observational cohort study. Subjects: A total of 28 eyes from 18 treatment-naive patients diagnosed with DME were included. Fourteen eyes were treated with faricimab, and fourteen eyes were treated with aflibercept 8 mg. Patients were selected based on clinical and imaging criteria confirming the presence of center-involving DME requiring anti-vascular endothelial growth factor (VEGF) therapy. Methods: Patients received loading doses of either four monthly faricimab injections or three aflibercept 8 mg injections and were followed for a total of approximately 6 to 9 months, including both loading and PRN phases. Primary outcomes included changes in best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR), central retinal thickness (CRT) assessed via optical coherence tomography (OCT), and the number of injections required. Secondary outcomes included fluid resolution rates based on OCT findings. Statistical comparisons between groups were performed using independent two-sample t-tests, with a p-value <0.05 considered statistically significant. Main Outcome Measures: Changes in BCVA, CRT, injection frequency, and fluid resolution. Results: The mean BCVA change was -0.12 logMAR for faricimab and -0.10 logMAR for aflibercept 8 mg (p = 0.41). The reductions in CRT were 96.2 µm and 91.6 µm, respectively (p = 0.58). The injection burden was similar, with an average of 5.71 injections for faricimab and 5.14 for aflibercept 8 mg (p = 0.32). Fluid resolution rates did not differ significantly between groups. No serious adverse events were reported. Conclusions: Both faricimab and aflibercept 8 mg demonstrated significant improvements in BCVA and CRT. While the results suggest comparable efficacy and safety between the two treatments, this conclusion should be interpreted cautiously due to the study's limitations. Specifically, the relatively small sample size and short follow-up duration. These findings highlight the importance of individualized treatment considerations, such as cost, accessibility, and patient preference. Further prospective studies are needed to validate these results and assess long-term treatment durability across different regimens.http://www.sciencedirect.com/science/article/pii/S2950253525000358Diabetic macular edemaFaricimabAflibercept 8 mgAnti-VEGF therapyComparative analysisPro re nata protocol |
| spellingShingle | Carlo Maccauro Yanny Jimenez Perez Piergiorgio Neri Ibraheem El Ghrably Haytham I Salti Francesco Pichi Short-term outcomes of faricimab and aflibercept 8 mg in diabetic macular edema AJO International Diabetic macular edema Faricimab Aflibercept 8 mg Anti-VEGF therapy Comparative analysis Pro re nata protocol |
| title | Short-term outcomes of faricimab and aflibercept 8 mg in diabetic macular edema |
| title_full | Short-term outcomes of faricimab and aflibercept 8 mg in diabetic macular edema |
| title_fullStr | Short-term outcomes of faricimab and aflibercept 8 mg in diabetic macular edema |
| title_full_unstemmed | Short-term outcomes of faricimab and aflibercept 8 mg in diabetic macular edema |
| title_short | Short-term outcomes of faricimab and aflibercept 8 mg in diabetic macular edema |
| title_sort | short term outcomes of faricimab and aflibercept 8 mg in diabetic macular edema |
| topic | Diabetic macular edema Faricimab Aflibercept 8 mg Anti-VEGF therapy Comparative analysis Pro re nata protocol |
| url | http://www.sciencedirect.com/science/article/pii/S2950253525000358 |
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