Lowest dose bevacizumab effective for Retinopathy of Prematurity: JAMA
It has become common practice in many neonatal intensive care nurseries to treat severe retinopathy of prematurity (ROP) by intravitreous injection of drugs blocking the bioactivity of vascular endothelial growth factor (VEGF). Bevacizumab is often used for this purpose, typically at doses of 0.25 mg to 0.625 mg, the latter being the dose that demonstrated efficacy in the Bevacizumab Eliminates the Angiogenic Threat of ROP (BEAT-ROP) trial. After intravitreous injection, bevacizumab is found in the systemic circulation and plasma VEGF levels decrease, so there are concerns about possible adverse effects. Vascular endothelial growth factor is necessary for normal development of tissues such as the brain, lungs, bones, kidneys, and retina, so blocking its action is potentially harmful to neonates. There is particular concern that anti-VEGF drugs could increase the risk of neurodevelopmental disability. To determine the lowest dose of bevacizumab that may be effective in severe ROP that warranted treatment (type 1), David K. Wallace and team conducted a masked, multicenter, dose de-escalation phase 1 study.
Between April 2017 and May 2019, 59 premature infants with type 1 ROP in 1 or both eyes were enrolled in a masked, multicenter, dose de-escalation study. In cohorts of 10 to 14 infants, 1 eye per infant received 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg of intravitreous bevacizumab. Diluted bevacizumab was prepared by individual research pharmacies and delivered using 300-μL syringes with 5/16-inch, 30-guage fixed needles. Analysis began July 2019.Success was defined as improvement by 4 days postinjection and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks.
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