Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial.
Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial.
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DOI：
10.1007/s12325-020-01579-5
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发表时间：
2021-03
影响因子：
3.8
通讯作者：
VEGA Investigators
中科院分区：
文献类型：
--
作者：
Inatani M;Higashide T;Matsushita K;Miki A;Ueki M;Iwamoto Y;Kobayashi M;Leal S;VEGA Investigators
新生血管性青光眼的特征在于虹膜和前房的新生血管形成。玻璃体内抗血管内皮生长因子药物可改善眼内压（IOP）和新生血管形成。VEGA试验评估了玻璃体内注射阿柏西普（IVT-AFL）在新生血管性青光眼患者中的疗效和安全性，这项为期13周的随机、双盲、假对照、III期研究在日本多个研究中心进行，招募了眼前段新生血管形成和IOP > 25 mmHg的患者。患者在基线时接受背景治疗加IVT-AFL（2 mg）或假注射。如果患者表现为IOP > 21 mmHg和虹膜新生血管不完全消退，则重新治疗，在第1周接受额外的假手术或IVT-AFL注射，并在第5周和/或第9周接受IVT-AFL注射。始终保持双盲。主要终点是IOP从基线至第1周的变化。随机分配54例患者（全分析集）;符合方案集包括52例患者。第1周时，IVT-AFL组IOP的最小二乘平均变化为−9.9 mmHg，假手术组为−5.0 mmHg [全分析集：差异为−4.9 mmHg（95%置信区间为−10.2至0.3; P = 0.06）;符合方案集：−5.5 mmHg（95% CI为−10.8至−0.2; P = 0.04）]。在第1周，接受IVT-AFL的患者中，达到IOP ≤ 21 mmHg的患者比例高于接受假手术的患者，且新生血管分级改善。假手术组中符合再治疗标准并在第1周接受IVT-AFL的患者[n = 22（81.5%）]在第2周时平均IOP额外降低9.2 mmHg，新生血管分级改善的比例从11.5%增加至69.2%。在该组中，第2周时还观察到新生血管形成等级改善的患者比例和达到IOP控制（≤ 21 mmHg）的患者比例增加。总体而言，分别有77.8%和74.1%接受IVT-AFL和假手术/IVT-AFL治疗的患者接受了单次IVT-AFL注射。最常见的眼部治疗后出现的不良事件是点状角膜炎（IVT-AFL组和假手术/IVT-AFL组分别为9.3%：7.4%和11.1%）。IVT-AFL与具有临床意义的IOP控制改善相关，表明IVT-AFL可能是新生血管性青光眼患者的潜在治疗选择。Clinicaltrials.gov标识符，NCT 02396316。本文的在线版本（10.1007/s12325-020-01579-5）包含补充材料，可供授权用户使用。
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. 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. 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). 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. Clinicaltrials.gov identifier, NCT02396316. The online version of this article (10.1007/s12325-020-01579-5) contains supplementary material, which is available to authorized users.
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DOI：
10.1159/000431196
发表时间：
2016-01-01
期刊：
RETINAL PHARMACOTHERAPEUTICS
影响因子：
--
作者：
Havens, Shane J.;Gulati, Vikas
通讯作者：
Gulati, Vikas
DOI：
10.1007/s00417-013-2428-y
发表时间：
2013-10-01
影响因子：
2.7
作者：
Lueke, Julia;Nassar, Khaled;Grisanti, Salvatore
通讯作者：
Grisanti, Salvatore
影响因子：
3.8
作者：
Andrés-Guerrero V;Perucho-González L;García-Feijoo J;Morales-Fernández L;Saenz-Francés F;Herrero-Vanrell R;Júlvez LP;Llorens VP;Martínez-de-la-Casa JM;Konstas AG
通讯作者：
Konstas AG
影响因子：
1.9
作者：
Shen X;Chen Y;Wang Y;Yang L;Zhong Y
通讯作者：
Zhong Y
新生血管性青光眼：中国三级中心的回顾性研究
影响因子：
2
作者：
Liao N;Li C;Jiang H;Fang A;Zhou S;Wang Q
通讯作者：
Wang Q