Short-Term Morphofunctional Changes in Previously Treated Neovascular AMD Eyes Switched to Brolucizumab

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Abstract

The purpose of the study is to explore the morphofunctional fluctuations in eyes treated for neovascular AMD (nAMD) when treatment is switched from aflibercept or ranibizumab to brolucizumab. A total of 31 eyes of 31 patients with nAMD with type 1 macular neovascularization (MNV) were included. All patients were imaged using spectral domain optical coherence tomography (SD-OCT). The OCT acquisition was performed at the following visits: (i) “T1 visit” corresponding to the last follow-up examination in which an intravitreal injection of aflibercept or ranibizumab was performed before switching to brolucizumab because of the lack of improvement and (ii) “T2 visit” corresponding to the examination performed 1 month after T1, the latter visit corresponding to the day when a switch to brolucizumab injection was performed, (iii) and 1 month after the latter injection “(T3)”. The main outcome measures were: (1) central macular thickness (CMT), (2) choroidal vascularity index (CVI), (3) subfoveal choroidal thickness (CT), and best-corrected visual acuity (BCVA). Functional outcome showed significant differences at each time. Mean ± SD BCVA was 0.43 ± 0.12 LogMAR at T1 and 0.56 ± 0.16 LogMAR at T2 (p = 0.038). A significant improvement in BCVA was displayed at T3 (0.34 ± 0.21 LogMAR) as compared with T2 (p = 0.019). CMT analysis showed fluctuations three times. In detail, T2 displayed a thicker CMT in comparison with T1, although not statistically significant (p = 0.12). Contrariwise, T3 showed a thinner CMT in comparison with T2 (p = 0.002). Analyzing CVI among the three different times, the luminal choroidal area (LCA) and total choroidal area (TCA) showed significantly different values before and after switching to brolucizumab. T2 showed a significant reduction in both vessel lumen and total area compared with T1 (p = 0.032 and p = 0.046, respectively). Moreover, T3 showed a greater value of both LCA and TCA in comparison with T2 (p = 0.008 and p = 0.01, respectively). CT did not show significant differences at each time (p > 0.05). Our results reported early experiences on morphofunctional fluctuations in patients with nAMD who switched to brolucizumab. The anatomical impact of brolucizumab administration appears to result in choroidal vascular enlargement, accompanied by the resolution of subretinal fluid (SRF) and intraretinal fluid (IRF).

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Ranibizumab for neovascular age-related macular degeneration.

Philip J. Rosenfeld, David M Brown, Jeffrey Heier … (2006)

Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P<0.001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the sham-injection group (P<0.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. (ClinicalTrials.gov number, NCT00056836 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.

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Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration.

Jeffrey Heier, David M Brown, Victor Chong … (2012)

Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Proprietary or commercial disclosure may be found after the references. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration

Pravin Dugel, Adrian Koh, Yuichiro Ogura … (2019)

Two similarly designed phase 3 trials (HAWK and HARRIER) compared brolucizumab, a single-chain antibody fragment that inhibits vascular endothelial growth factor-A, with aflibercept to treat neovascular age-related macular degeneration (nAMD).