Abstract
Purpose
To evaluate 1-year outcomes of loading phase treatment followed by maintenance therapy using a treat-and-extend (TAE) regimen with intravitreal faricimab for neovascular age-related macular degeneration (nAMD).
Study design
Retrospective, interventional case series.
Methods
We retrospectively studied 40 eyes of 38 consecutive patients with treatment-naïve nAMD, assessing best-corrected visual acuity (BCVA), foveal thickness, central choroidal thickness (CCT), total number of injections over 1 year, and intended injection interval at the last visit.
Results
Thirty eyes (75.0%) had completed the 1-year intravitreal faricimab treatment. Their BCVA showed significant improvement, with significant reductions in foveal thickness and CCT. The total number of injections during the 1-year treatment period was 6.6 ± 0.7. The intended injection interval at the last visit was 12.7 ± 3.3 weeks. Of the 10 eyes (25.0%) failing to complete the 1-year faricimab treatment, 1 eye developed intraocular inflammation after the loading phase treatment but showed no recurrence of exudative changes, and no further treatment was required. Moreover, 5 eyes switched to intravitreal brolucizumab injection due to persistent exudative changes with an 8-week interval of faricimab injections. The remaining 4 eyes either dropped out or the patient died.
Conclusions
A loading phase treatment followed by a TAE regimen with intravitreal faricimab appears to be generally safe and effective for improving visual acuity and ameliorating exudative changes in eyes with nAMD. However, there might be cases in which exudative changes cannot be adequately controlled with injections of faricimab every 8 weeks in the maintenance phase.
Similar content being viewed by others
References
Yamashiro K, Oishi A, Hata M, Takahashi A, Tsujikawa A. Visual acuity outcomes of anti-VEGF treatment for neovascular age-related macular degeneration in clinical trials. Jpn J Ophthalmol. 2021;65:741–60.
Ferrara N, Damico L, Shams N, Lowman H, Kim R. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina. 2006;26:859–70.
Papadopoulos N, Martin J, Ruan Q, Rafique A, Rosconi MP, Shi E, et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF trap, ranibizumab and bevacizumab. Angiogenesis. 2012;15:171–85.
Nguyen QD, Das A, Do DV, Dugel PU, Gomes A, Holz FG, et al. Brolucizumab: evolution through preclinical and clinical studies and the implications for the management of neovascular age-related macular degeneration. Ophthalmology. 2020;127:963–76.
Regula JT, von Lundh P, Foxton R, Barathi VA, Cheung CM, Bo Tun SB, et al. Targeting key angiogenic pathways with a bispecific CrossMAb optimized for neovascular eye diseases. EMBO Mol Med. 2016;8:1265–88.
Dugel PU, Koh A, Ogura Y, Jaffe GJ, Schmidt-Erfurth U, Brown DM, et al. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127:72–84.
Dugel PU, Singh RP, Koh A, Ogura Y, Weissgerber G, Gedif K, et al. HAWK and HARRIER: ninety-six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2021;128:89–99.
Matsumoto H, Hoshino J, Mukai R, Nakamura K, Akiyama H. Short-term outcomes of intravitreal brolucizumab for treatment-naive neovascular age-related macular degeneration with type 1 choroidal neovascularization including polypoidal choroidal vasculopathy. Sci Rep. 2021;11:6759.
Matsumoto H, Hoshino J, Mukai R, Nakamura K, Akiyama H. One-year results of treat-and-extend regimen with intravitreal brolucizumab for treatment-naive neovascular age-related macular degeneration with type 1 macular neovascularization. Sci Rep. 2022;12:8195.
Matsumoto H, Hoshino J, Nakamura K, Akiyama H. Two-year outcomes of treat-and-extend regimen with intravitreal brolucizumab for treatment-naive neovascular age-related macular degeneration with type 1 macular neovascularization. Sci Rep. 2023;13:3249.
Yamamoto A, Okada AA, Kano M, Koizumi H, Saito M, Maruko I, et al. One-year results of intravitreal aflibercept for polypoidal choroidal vasculopathy. Ophthalmology. 2015;122:1866–72.
Koizumi H, Kano M, Yamamoto A, Saito M, Maruko I, Kawasaki R, et al. Short-term changes in choroidal thickness after aflibercept therapy for neovascular age-related macular degeneration. Am J Ophthalmol. 2015;159:627–33.
Morimoto M, Matsumoto H, Mimura K, Akiyama H. Two-year results of a treat-and-extend regimen with aflibercept for polypoidal choroidal vasculopathy. Graefes Arch Clin Exp Ophthalmol. 2017;255:1891–7.
Hikichi T, Higuchi M, Matsushita T, Kosaka S, Matsushita R, Takami K, et al. One-year results of three monthly ranibizumab injections and as-needed reinjections for polypoidal choroidal vasculopathy in Japanese patients. Am J Ophthalmol. 2012;154:117–24 (e1).
Yamazaki T, Koizumi H, Yamagishi T, Kinoshita S. Subfoveal choroidal thickness after ranibizumab therapy for neovascular age-related macular degeneration: 12-month results. Ophthalmology. 2012;119:1621–7.
Koh A, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, et al. Efficacy and safety of Ranibizumab with or without verteporfin photodynamic therapy for polypoidal choroidal vasculopathy: a randomized clinical trial. JAMA Ophthalmol. 2017;135:1206–13.
Patil NS, Dhoot AS, Popovic MM, Kertes PJ, Muni RH. Risk of intraocular inflammation after injection of antivascular endothelial growth factor agents: a meta-analysis. Retina. 2022;42:2134–42.
Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022;399:729–40.
Matsumoto H, Hoshino J, Nakamura K, Nagashima T, Akiyama H. Short-term outcomes of intravitreal faricimab for treatment-naive neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2023;261:2945–52.
Mukai R, Kataoka K, Tanaka K, Miyara Y, Maruko I, Nakayama M, et al. Three-month outcomes of faricimab loading therapy for wet age-related macular degeneration in Japan. Sci Rep. 2023;13:8747.
Maruyama-Inoue M, Yanagi Y, Inoue T, Kadonosono K. Comparison of functional and morphologic changes between brolucizumab and faricimab in neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2023.
Spaide RF, Jaffe GJ, Sarraf D, Freund KB, Sadda SR, Staurenghi G, et al. Consensus nomenclature for reporting neovascular age-related macular degeneration data: consensus on neovascular age-related macular degeneration nomenclature study group. Ophthalmology. 2020;127:616–36.
Iijima H, Iida T, Imai M, Gohdo T, Tsukahara S. Optical coherence tomography of orange-red subretinal lesions in eyes with idiopathic polypoidal choroidal vasculopathy. Am J Ophthalmol. 2000;129:21–6.
Yanai H. Statcel—the useful add-in software forms on Excel. 4th ed. Tokyo: OMS; 2015.
Ohji M, Takahashi K, Okada AA, Kobayashi M, Matsuda Y, Terano Y, et al. Efficacy and safety of intravitreal aflibercept treat-and-extend regimens in exudative age-related macular degeneration: 52- and 96-week findings from ALTAIR: a randomized controlled trial. Adv Ther. 2020;37:1173–87.
Chugai Pharmaceutical Co., Ltd. Faricimab CTD: 2.7.2.2.4.3.3. Pharmacodynamics, 2022. Available at: https://www.pmda.go.jp/drugs/2022/P20220406001/index.html. Accessed 25th Oct 2023 (in Japanese).
Angermann R, Huber AL, Nowosielski Y, Salcher S, Gasser T, Seifarth C, et al. Changes in systemic levels of vascular endothelial growth factor after intravitreal injection of aflibercept or brolucizumab for neovascular age-related macular degeneration. Retina. 2022;42:503–10.
Schmidt-Erfurth U, Mulyukov Z, Gerendas BS, Reiter GS, Lorand D, Weissgerber G, et al. Therapeutic response in the HAWK and HARRIER trials using deep learning in retinal fluid volume and compartment analysis. Eye (Lond). 2023;37:1160–9.
Ohji M, Okada AA, Sasaki K, Moon SC, Machewitz T, Takahashi K, et al. Relationship between retinal fluid and visual acuity in patients with exudative age-related macular degeneration treated with intravitreal aflibercept using a treat-and-extend regimen: subgroup and post-hoc analyses from the ALTAIR study. Graefes Arch Clin Exp Ophthalmol. 2021;259:3637–47.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflicts of interest
H. Matsumoto, None; J. Hoshino, None; K. Nakamura, None; H. Akiyama, None.
Additional information
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Corresponding Author: Hidetaka Matsumoto
About this article
Cite this article
Matsumoto, H., Hoshino, J., Nakamura, K. et al. One-year results of treat-and-extend regimen with intravitreal faricimab for treatment-naïve neovascular age-related macular degeneration. Jpn J Ophthalmol 68, 83–90 (2024). https://doi.org/10.1007/s10384-023-01040-4
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10384-023-01040-4