■尽管在临床试验中的发生率有限,但在临床实践中监测和报告眼内炎症(IOI)的潜在病例,包括使用相对较新的玻璃体内药物的经验,例如brolucizumab,pegcetacoplan,或者法利玛,有助于平衡这些代理商的潜在利益和风险。
■为了描述3例最初的急性培养阴性病例,严重,后段IOI事件发生在同一机构玻璃体内注射法西单抗后的同一个月内.
■在这种情况下,3例患者表现为急性,在2023年9月20日至2023年10月20日期间发现了玻璃体内注射法利单抗后的严重IOI.
■Faricimab,6毫克(0.05毫升120毫克/毫升溶液),既往接受过阿柏西普治疗的患者中的新生血管性年龄相关性黄斑变性;1例患者之前也曾接受过贝伐单抗治疗.
■视力,用于细菌或真菌培养的玻璃体水龙头,和视网膜成像。
■所有3名患者在2023年9月20日至10月20日之间接受了玻璃体内法罗单抗注射,来自2个不同的批号(有效期,2025年7月),在19名视网膜医生中的3名中,有1个机构的3个地点。在注射之前,具有矫正的视敏度对于患者1是20/63OS,对于患者2是20/40OD,并且对于患者3是20/20OS。所有3例患者均发展为急性,严重的炎症累及前段和后段在注射后3至4天,具有手部动作OS的视力,计算手指OD,和手部运动操作系统,分别。两名患者正在继续法利单抗治疗,而一名患者正在开始法利单抗治疗。都接受了玻璃体内头孢他啶,2.2mg/0.1mL,和万古霉素,1毫克/0.1毫升,玻璃体水龙头后立即。所有玻璃体水龙头培养结果均为阴性。一名患者在出现后1天接受了玻璃体切除术。术中玻璃体培养培养出1个表皮葡萄球菌菌落,传染病专家判断可能是污染物。所有症状均在1个月内缓解;患者1的矫正视力为20/100OS,患者2的20/50OD,患者3的20/30OS。
■在这种情况下,3例急性,1个机构的3名眼科医生在玻璃体内注射faricimab后1个月内3个不同地点出现严重IOI,可能代表一些未知的储存或处理问题.然而,这群表明,此类炎症事件可能比法利单抗试验报告中预期的更常见,强调在监管机构批准后,需要继续保持警惕,以发现和报告此类案件。
UNASSIGNED: Monitoring for and reporting potential cases of intraocular inflammation (IOI) in clinical practice despite limited occurrences in clinical trials, including experiences with relatively new intravitreal agents, such as brolucizumab, pegcetacoplan, or faricimab, helps balance potential benefits and risks of these agents.
UNASSIGNED: To provide descriptions of 3 initially culture-negative cases of acute, severe, posterior-segment IOI events occurring within the same month following intravitreal faricimab injections at a single institution.
UNASSIGNED: In this case series, 3 patients manifesting acute, severe IOI following intravitreal injection of faricimab were identified between September 20, 2023, and October 20, 2023.
UNASSIGNED: Faricimab, 6 mg (0.05 mL of 120 mg/mL solution), for neovascular age-related macular degeneration among patients previously treated with aflibercept; 1 patient also had prior exposure to bevacizumab.
UNASSIGNED: Visual acuity, vitreous taps for bacterial or fungal cultures, and retinal imaging.
UNASSIGNED: All 3 patients received intravitreal faricimab injections between September 20 and October 20, 2023, from 2 different lot numbers (expiration dates, July 2025) at 3 locations of 1 institution among 3 of 19 retina physicians. Visual acuities with correction were 20/63 OS for patient 1, 20/40 OD for patient 2, and 20/20 OS for patient 3 prior to injection. All 3 patients developed acute, severe inflammation involving the anterior and posterior segment within 3 to 4 days after injection, with visual acuities of hand motion OS, counting fingers OD, and hand motion OS, respectively. Two patients were continuing faricimab treatment while 1 patient was initiating faricimab treatment. All received intravitreal ceftazidime, 2.2 mg/0.1 mL, and vancomycin, 1 mg/0.1 mL, immediately following vitreous taps. All vitreous tap culture results were negative. One patient underwent vitrectomy 1 day following presentation. Intraoperative vitreous culture grew 1 colony of Staphylococcus epidermidis, judged a likely contaminant by infectious disease specialists. All symptoms resolved within 1 month; visual acuities with correction were 20/100 OS for patient 1, 20/50 OD for patient 2, and 20/30 OS for patient 3.
UNASSIGNED: In this case series, 3 patients with acute, severe IOI within 1 month at 3 different locations among 3 ophthalmologists of 1 institution following intravitreal faricimab could represent some unknown storage or handling problem. However, this cluster suggests such inflammatory events may be more common than anticipated from faricimab trial reports, emphasizing the continued need for vigilance to detect and report such cases following regulatory approval.