Intravitreal sirolimus with adjunct aflibercept versus aflibercept monotherapy for persistent, exudative age-related macular degeneration: a pilot study

International Journal of Retina and Vitreous

Original Article

Lucas W. Rowe¹  Robert J. Minturn¹  Raj K. Maturi²  Lauren A. Burgett³  Peter Bracha⁴ 

[1] Department of Ophthalmology, Indiana University School of Medicine, 10300 N Illinois St, Suite 1060, 46290, Indianapolis, IN, USA;Department of Ophthalmology, Indiana University School of Medicine, 10300 N Illinois St, Suite 1060, 46290, Indianapolis, IN, USA;Midwest Eye Institute, Indianapolis, IN, USA;Department of Psychology and Neuroscience, Duke University, Durham, NC, USA;Wolfe Eye Clinic, West Des Moines, IA, USA;

关键词: Sirolimus;    Rapamycin;    Aflibercept;    Eylea;    Anti-vascular endothelial growth factor;    Exudative age-related macular degeneration;   

DOI  :  10.1186/s40942-022-00437-6

 received in 2022-11-06, accepted in 2022-12-23,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundTo determine the safety and efficacy of intravitreal sirolimus and adjunct aflibercept in subjects with persistent, exudative age-related macular degeneration despite previous intravitreal anti-vascular endothelial growth factor (VEGF) treatment.MethodsThis institutional review board approved, registered (NCT02732899), prospective, subject-masked, single center, randomized controlled trial in subjects with persistent, exudative age-related macular degeneration compared alternating monthly intravitreal sirolimus and aflibercept (combination) versus aflibercept monotherapy (control) every 2 months over the course of 36 weeks. The primary measure of efficacy in the study was the mean change in central subfield thickness.Results20 subjects were enrolled in the study, with 10 subjects assigned to each treatment group. Subjects had an average of 38 previous anti-VEGF injections. Mean central subfield thickness decreased in the combination group by 54.0 μm compared to 0.1 μm in the control group (p = 0.28). Mean visual acuity improved in the combination group by 2.5 ETDRS letters versus 0.8 ETDRS letters in the control group (p = 0.42). There were no serious ocular adverse events in either group; however, there were three serious systemic events in the combination group, including hospitalizations due to pancreatitis, pneumonia, and worsening hypertension.ConclusionThere was no statistically significant difference in the mean central subfield thickness change between the combination and control groups. However, intravitreal sirolimus with adjunct aflibercept did appear to have potential anatomical benefits as a treatment for persistent, exudative age-related macular degeneration and requires further investigation with a larger cohort to better understand the potential risks and benefits.Trial registration: ClinicalTrials.gov, NCT02732899. Registered 11 March 2016, https://clinicaltrials.gov/ct2/show/NCT02732899. This trial was approved by the institutional review board at Advarra. Funding was provided by an investigator-initiated grant from Santen. Santen played no role in the design or implementation of this study.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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