Postoperative Ocular Inflammation: A Single Subconjunctival Injection of XG-102 Compared to Dexamethasone Drops in a Randomized Trial

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• 作者：Christophe Chiquet^a ; ^{christophe.chiquet@inserm.fr} ; Florent Aptel^a ; Catherine Creuzot-Garcher^b ; Jean-Paul Berrod^c ; Laurent Kodjikian^d ; Pascale Massin^e ; Catherine Deloche^f ; Julien Perino^f ; Bridget-Anne Kirwan^g ; Sophie de Brouwer^g ; Jean-Marc Combette^f ; Francine Behar-Cohen^h
• 刊名：American Journal of Ophthalmology
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：174
• 期：Complete
• 页码：76-84
• 全文大小：1282 K
• 卷排序：174

文摘

To evaluate the efficacy and safety of XG-102 (brimapitide) compared to dexamethasone eye drops in the treatment of postoperative ocular inflammation.DesignMulticenter, randomized, parallel group, double-masked, noninferiority clinical trial.MethodsPatients who underwent anterior and posterior segments combined surgery or glaucoma surgery or complex posterior segment surgery were eligible to participate. Patients were administered a single subconjunctival injection of 250 μL XG-102 90 μg (n = 47) or 900 μg (n = 48) or placebo (n = 50) at the end of ocular surgery. Subconjunctival injection for each group (XG-102 90 μg, XG-102 900 μg, or placebo) was followed by eye drops instilled 4 times per day for 21 days with placebo, placebo, or dexamethasone solution, respectively. The primary outcome measure was anterior chamber cell grades at day 28 comparing XG-102 900 μg with dexamethasone.ResultsThe anterior cell grades for both XG-102 groups were noninferior to dexamethasone (−0.054 anterior cell grade [95% confidence interval −0.350–0.242]; P < .001 for noninferiority) for XG-102 900 μg and −0.086 anterior cell grade (95% confidence interval −0.214–0.385; P = .003 for noninferiority) for XG-102 90 μg. Rescue medication was introduced for 10 (21%), 7 (15%), and 2 (4%) patients allocated to the XG-102 90 μg, XG-102 900 μg, and dexamethasone groups, respectively. The difference between XG-102 90 μg and dexamethasone was statistically significant (P = .013). The number of patients for whom adverse events were reported and the nature of the events reported was similar between the 3 treatment groups.ConclusionsA single subconjunctival injection of XG-102 at the end of ocular surgery is noninferior to dexamethasone eye drops in the treatment of postoperative ocular inflammation.