Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

Abstract

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

Long Intervals between Intravitreal Injections Using a Treat-and-Extend Protocol in a Real-Life Context in AMD: The LIRE Study

“…Other studies have shown different distributions of the CNV subtypes, with subtype 1 found in 34-61% of eyes and subtype 3 in 2-40% of eyes [22,[25][26][27]. The predominance of type 1 CNV in our study is in accordance with the recent publications by Mathis et al [28,29].…”

“…Many pivotal prospective studies have reported higher rates of eyes treated Q12W from 42 to 60% in the ARIES ALTAIR and VIEW studies [4, 20, 21]. Our results are closer to the rates of 32–37% reported in the recent real-life studies with a shorter follow-up [22–24]. However, our study being cross-sectional, our cohort included all eyes injected during a fixed period regardless of the protocol initially used (directly and lately treated with the TE regimen).…”

“…This could explain why no VA gain was perceptible. The high baseline BCVA observed in our study could be due to good public information and screening, allowing early detection and management of AMD in the past few years, as shown by Keenan et al [35] and in other French studies [22, 35]. On the other hand, the baseline BCVA was maintained in our cohort after a long follow-up (47 months), which was remarkable despite an increased RPE atrophy rate.…”

“…Regarding the secondary outcomes, we found that a higher number of IVIs (over a longer time) was needed to reach a Q12W TE treatment interval compared to other studies [20,22]. Indeed, our total cohort included naiveand delayed-TE protocols, and the mean follow-up duration before initiating the TE protocol was long (about 21 months).…”

“…It is well known that the frequency and extent of atrophy increase over time in nAMD [41]. Other studies have reported different rates depending on the time and the RPE atrophy detection methods: between 37% and 70% at 2 years, 40% at 5 years in the CATT post hoc analysis, and 98% in the SEVEN-UP study at 7 years [22, 42–44]. However, it should be noted that our population maintained a good visual acuity throughout the follow-up.…”