Witkin Andre J, Jaffe Glenn J, Srivastava Sunil K, Davis Janet L, Kim Judy E
Tufts Medical Center, Boston, MA, USA.
Duke University, Durham, NC, USA.
J Vitreoretin Dis. 2023 Dec 21;8(1):9-20. doi: 10.1177/24741264231220224. eCollection 2024 Jan-Feb.
To analyze post-marketing cases of retinal vasculitis after intravitreal pegcetacoplan. The American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee as well as an expert panel performed a retrospective review of cases of retinal vasculitis reported to the ASRS. Clinical and imaging characteristics were reviewed for evidence of retinal vasculitis and analyzed. Fourteen eyes of 13 patients were confirmed to have retinal vasculitis by review of imaging studies. All cases occurred after the first pegcetacoplan injection. Occlusive retinal vasculopathy was confirmed in 11 eyes (79%). Patients presented a median of 10.5 days (range, 8-23 days) after pegcetacoplan injection. All eyes had anterior chamber inflammation, and 12 eyes (86%) had vitritis. Vasculopathy involved retinal veins (100%) more than arteries (73%), and 12 eyes (86%) had retinal hemorrhages. The median visual acuity (VA) was 20/60 (range, 20/30-5/200) at baseline, 20/300 (range, 20/100-no light perception [NLP]) at vasculitis presentation, and 20/200 (range 20/70-NLP) at the last follow-up. Eight eyes (57%) had more than a 3-line decrease in VA, and 6 eyes (43%) had more than a 6-line decrease in VA from baseline to the final follow-up, including 2 eyes that were enucleated. Six eyes (43%) developed signs of anterior segment neovascularization. There is currently no known etiology for vasculitis in this series. Optimum treatment strategies remain unknown. Infectious etiologies should be considered, and corticosteroid treatments may hasten resolution of inflammatory findings. Continued treatment of affected patients with pegcetacoplan should be avoided.
分析玻璃体内注射培西加可普兰后视网膜血管炎的上市后病例。美国视网膜专家协会(ASRS)治疗研究与安全(ReST)委员会以及一个专家小组对向ASRS报告的视网膜血管炎病例进行了回顾性审查。对临床和影像学特征进行了审查,以寻找视网膜血管炎的证据并进行分析。经影像学研究审查,13例患者的14只眼被确诊为视网膜血管炎。所有病例均发生在首次注射培西加可普兰之后。11只眼(79%)确诊为闭塞性视网膜血管病变。患者在注射培西加可普兰后的中位时间为10.5天(范围8 - 23天)。所有患眼均有前房炎症,12只眼(86%)有玻璃体炎。血管病变累及视网膜静脉的比例(100%)高于动脉(73%),12只眼(86%)有视网膜出血。基线时的中位视力(VA)为20/60(范围20/30 - 5/200),血管炎出现时为20/300(范围20/100 - 无光感[NLP]),最后一次随访时为20/200(范围20/70 - NLP)。8只眼(57%)的视力下降超过3行,6只眼(43%)从基线到最终随访时视力下降超过6行,其中包括2只已摘除眼球的眼。6只眼(43%)出现了前段新生血管形成的体征。该系列中目前尚无已知的血管炎病因。最佳治疗策略仍不明确。应考虑感染性病因,皮质类固醇治疗可能会加速炎症表现的消退。应避免继续用培西加可普兰治疗受影响的患者。