Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial
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ORIGINAL RESEARCH
Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial Masaru Inatani . Tomomi Higashide . Kenji Matsushita . Atsuya Miki . Mari Ueki . Yuji Iwamoto . Masato Kobayashi . Sergio Leal . for the VEGA Investigators
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 the anterior angle chamber. Intravitreal anti-vascular endothelial growth factor agents may
The members list for the VEGA Investigators are mentioned in ‘‘Acknowledgements’’ section.
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12325020-01579-5) contains supplementary material, which is available to authorized users. 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 A. Miki Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan M. Ueki Department of Ophthalmology, Osaka Medical College, Takatsuki-City, Osaka, Japan Y. Iwamoto M. Kobayashi Bayer Yakuhin, Ltd., Osaka, Japan S. Leal Bayer Consumer Care AG, Basel, Switzerland
improve intraocular pressure (IOP) and neovascularization. Methods: The VEGA trial assessed the efficacy and safety of intravitreal aflibercept (IVT-AFL) in patients with neovascular glaucoma in a 13-week, randomized, double-masked, shamcontrolled, phase 3 study performed at multiple sites in Japan that enrolled patients with anterior segment neovascularization and IOP [ 25 mmHg. Patients received background therapy plus IVT-AFL (2 mg) or sham injection at baseline. Patients were re-treated if presenting with IOP [ 21 mmHg and incomplete regression of iris neovascularization, receiving additional sham or IVT-AFL injections at week 1 and IVT-AFL injections at weeks 5 and/or 9. Double-masking was maintained throughout. The primary endpoint was change in IOP from baseline to week 1. Results: Fifty-four patients were randomly assigned (full analysis set); the per-protocol set comprised 52 patients. At week 1, the least squares mean change in IOP was -9.9 mmHg for IVT-AFL versus -5.0 mmHg for sham [full analysis set: difference -4.9 mmHg (95% confidence interval -10.2 to 0.3; P = 0.06); perprotocol set: -5.5 mmHg (95% CI -10.8 to -0.2; P = 0.04)]. At week 1, a greater proportion of patients administered IVT-AFL versus sham achieved IOP B 21 mmHg and had improved neovascularization grades. Patients in the sham group who met re-treatment criteria and received IVT-AFL at week 1 [n = 22 (81.5%)] had
Adv Ther
an additional mean IOP decrease of 9.2 mmHg by week 2, and the proportion with improvement in neovascularization grades increased from 11.5% to 69.2%. Increases in the proportion of patients with improved neovascularization grades and the proporti
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