Intravitreal aflibercept efficacy in neovascular age-related macular degeneration with suboptimal response to anti-vascular endothelial growth factor-A therapy

Abstract

Importance: To provide new insights into aflibercept effect in non-naive-treated patients with neovascular age-related macular degeneration. Purpose: To assess the efficacy of intravitreal aflibercept in patients with neovascular age-related macular degeneration without optimal response to previous anti-vascular endothelial growth factor A therapy. Design: Single-arm, multi-centre, prospective study. Participants: Patients ⩾50 years with active neovascular age-related macular degeneration, best-corrected visual acuity between 20/32 and 20/320 with suboptimal response to ranibizumab or bevacizumab. Methods: Aflibercept was administered monthly (3-first months), and bimonthly thereafter until month 8. Anatomical and functional outcomes were assessed. Main outcome measure: Percentage of eyes without intra or subretinal fluid on optical coherence tomography after 3-monthly loading doses of aflibercept. Results: A total of 46 patients were included. At week 12, 45.7% (95% confidence interval: 31.5%–60.1%) of eyes showed no fluid on optical coherence tomography. The mean (standard deviation) best-corrected visual acuity increased from 65.1 (8.3) to 69.6 (8.1) letters (+4.5 (5.8) p < 0.0001) and was stabilized at week 40 as compared to baseline. Mean central macular thickness decreased from 430 (119) µm to 323 (100) µm at week 12 (–107 (90) µm, p < 0.0001) and was reduced at week 40 (–46 (111) µm, p = 0.0056). At week 40, 21.7% (95% confidence interval: 9.8%–33.7%) had no fluid. There was a case of presumed noninfectious endophthalmitis that was successfully managed. Conclusion: Almost half of patients presented no fluid on optical coherence tomography at week 12, and there was a clinically significant improvement in best-corrected visual acuity. At week 40, one in five patients did not show intra or subretinal fluid, central macular thickness decreased and best-corrected visual acuity was stabilized compared to baseline.

Clinical Comparative Study of Intravitreal Injection of Triamcinolone Acetonide and Aflibercept in the Treatment of Diabetic Retinopathy Cystoid Macular Edema

“…Finally, this study found that the incidence of adverse reactions in the observation group was lower than that in the control group, suggesting that intravitreal injection of aflibercept in the treatment of DR cystoid macular edema is safe, which is consistent with what Monés et al [ 20 ] has proposed. However, the average number of injections in the observation group was higher than that in the control group.…”

High-Dose Aflibercept for Neovascular AMD and DME in Suboptimal Responders to Standard-Dose Aflibercept

“…Consistent with this, several studies of eyes with nAMD have shown that switching to aflibercept 2 mg can improve visual and anatomic outcomes, although in some cases also allowing for extension of the dosing interval in eyes with a suboptimal response to ranibizumab or bevacizumab. 33–36 In a small study, aflibercept HD was effective in 38 eyes (33 patients) with nAMD that did not respond to standard doses of ranibizumab or bevacizumab. 10…”

“…Consistent with this, several studies of eyes with nAMD have shown that switching to aflibercept 2 mg can improve visual and anatomic outcomes, although in some cases also allowing for extension of the dosing interval in eyes with a suboptimal response to ranibizumab or bevacizumab. [33][34][35][36] In a small study, aflibercept HD was effective in 38 eyes (33 patients) with nAMD that did not respond to standard doses of ranibizumab or bevacizumab. 10 The present analysis extends these findings by showing the potential benefits of aflibercept HD therapy in eyes resistant to anti-VEGF agents with a broader range of indications for intensifying treatment for a cohort that is larger than in previous studies.…”

Faricimab (Vabysmo)

“…78 In a prospective, single arm, multi-centre study with 46 nAMD patients undergoing aflibercept treatment for 3 months, 45.7% (95% CI, 31.5%-60.1%) presented no IRF or SRF on OCT imaging at week 12, and a clinically significant improvement was found for BCVA [mean (SD); +4.5 (5.8) P < 0.0001]. 97 In the retrospective study of patients with AMD switched from ranibizumab to aflibercept treatment, there was almost perfect agreement 98 between raters for identifying presence of IRF on SD-OCT exams (Kappa statistic of 0.859) and substantial agreement 98 between raters for SRF (Kappa statistic of 0.713). 23 Another study 99 using a sample of 270 TD-OCT exams from the CATT found good agreement 98 between reading teams (with each team composed of 2 certified readers and one senior reader to reconcile discrepancies) at a reading centre for identifying presence of IRF (Kappa statistic of 0.48) and substantial agreement for identifying presence of SRF (Kappa statistic of 0.80).…”