1. Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial
- Author
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Atsuya Miki, Masaru Inatani, Yuji Iwamoto, Kenji Matsushita, Sergio Leal, Tomomi Higashide, Masato Kobayashi, Mari Ueki, and Vega Investigators
- Subjects
Intraocular pressure ,medicine.medical_specialty ,genetic structures ,Recombinant Fusion Proteins ,Neovascularization of the angle ,Visual Acuity ,Phases of clinical research ,Angiogenesis Inhibitors ,Neovascular glaucoma ,law.invention ,Neovascularization ,Japan ,Randomized controlled trial ,law ,Ophthalmology ,medicine ,Clinical endpoint ,Humans ,Pharmacology (medical) ,Neovascularization of the iris ,Adverse effect ,Anti-vascular endothelial growth factor ,Original Research ,Aflibercept ,business.industry ,Anti-VEGF ,General Medicine ,eye diseases ,Confidence interval ,Bevacizumab ,Glaucoma, Neovascular ,Receptors, Vascular Endothelial Growth Factor ,NVG ,Intravitreal Injections ,sense organs ,Intravitreal aflibercept ,medicine.symptom ,business ,medicine.drug - Abstract
Introduction Neovascular glaucoma is characterized by neovascularization of the iris and the anterior angle chamber. Intravitreal anti-vascular endothelial growth factor agents may 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, sham-controlled, 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); per-protocol 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 ≤ 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 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 proportion who achieved IOP control (≤ 21 mmHg) were also observed by week 2 in this group. Overall, 77.8% and 74.1% of patients treated with IVT-AFL and sham/IVT-AFL, respectively, received a single IVT-AFL injection. The most common ocular treatment-emergent adverse event was punctate keratitis (9.3%: 7.4% and 11.1% in the IVT-AFL and sham/IVT-AFL groups, respectively). Conclusions IVT-AFL was associated with clinically meaningful improvements in IOP control, indicating that IVT-AFL may be a potential treatment option for patients with neovascular glaucoma. Trial Registration Clinicaltrials.gov identifier, NCT02396316. Electronic supplementary material The online version of this article (10.1007/s12325-020-01579-5) contains supplementary material, which is available to authorized users.
- Published
- 2020
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