Efficacy and Safety of Intravitreal Aflibercept Injection in Japanese Patients with Neovascular Glaucoma: Outcomes from
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ORIGINAL RESEARCH
Efficacy and Safety of Intravitreal Aflibercept Injection in Japanese Patients with Neovascular Glaucoma: Outcomes from the VENERA Study Masaru Inatani . Tomomi Higashide . Kenji Matsushita . Daisuke Nagasato . Hitoshi Takagi . Mari Ueki . Yasuyuki Takai . Ken Miyazaki . Yuji Iwamoto . Masato Kobayashi . Sergio Leal
Received: October 20, 2020 / Accepted: November 19, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Neovascular glaucoma is characterized by neovascularization of the iris and anterior angle chamber. Intravitreal anti-vascular endothelial growth factor agents may decrease intraocular pressure (IOP) and improve neovascularization. The VENERA study assessed the efficacy and safety of intravitreal aflibercept (IVT-AFL) in patients with neovascular glaucoma. Methods: This was a 5-week, single-arm, nonrandomized, open-label, phase 3 study performed at 7 study sites in Japan that enrolled
Supplementary Information The online version contains supplementary material available at https:// doi.org/10.1007/s12325-020-01580-y. M. Inatani (&) Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan e-mail: [email protected] T. Higashide Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan K. Matsushita Department of Ophthalmology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan D. Nagasato Department of Ophthalmology, Saneikai Tsukazaki Hospital, Hyogo, Japan
Japanese patients with anterior segment neovascularization and IOP [ 25 mmHg who had not undergone (within 30 days prior), nor were imminently scheduled to undergo (within 8 days following) intraocular surgeries, including panretinal photocoagulation (PRP). Patients received background therapy plus 2 mg IVT-AFL at baseline. Background therapy with systemic IOP-lowering drugs was prohibited for 3 days before day 1 and until IOP evaluation at week 1. The primary endpoint was the change in IOP from baseline to week 1 and the secondary endpoint was the proportion of patients with an improvement of C 1 grade of neovascularization of the angle (NVA) from baseline to week 1. Results: Sixteen patients received treatment (full analysis set); the per-protocol set comprised 15 patients. The mean IOP decreased H. Takagi Department of Ophthalmology, St. Marianna University School of Medicine, Kanagawa, Japan M. Ueki Department of Ophthalmology, Osaka Medical College, Takatsuki, Osaka, Japan Y. Takai Department of Ophthalmology, Faculty of Medicine, Shimane University, Shimane, Japan K. Miyazaki Y. Iwamoto M. Kobayashi Bayer Yakuhin, Ltd., Osaka, Japan S. Leal Bayer Consumer Care AG, Basel, Switzerland
Adv Ther
from 34.1 mmHg at baseline to 25.8 mmHg at week 1 (mean change, -8.3 mmHg [95% confidence interval; CI -12.2 to -4.4; P = 0.0004]). At week 1, 81.3% of patients had an improvement in the grade of neovascularization of the iris (NVI) and 50.0% of patients had an improvement in NVA grade. The proportion of patients with controlled IOP (
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