Bevacizumab at a lower than standard dose might be effective to treat severe retinopathy of prematurity and possibly reduce the risk for neurodevelopmental delay, according to a study.
Intravitreal use of anti-VEGFs has become common practice to treat ROP, but concerns remain about possible adverse effects on the normal development of the brain, lungs, bones, kidneys and retina. The recommended dose of bevacizumab is currently between 0.25 mg and 0.625 mg, the latter being the dose that showed efficacy in the BEAT-ROP trial.
In a masked multicenter study, the Pediatric Eye Disease Investigator Group evaluated the possibility of achieving comparable efficacy in severe ROP using lower doses of the drug. Four doses were evaluated: 0.016 mg, 0.008 mg, 0.004 mg and 0.002 mg in groups of 10 to 14 infants with a follow-up of 4 weeks. Fifty-nine premature infants with ROP were enrolled between April 2017 and May 2019. Diluted bevacizumab was prepared by individual hospital pharmacies. Success was defined as improvement by day 4 with no additional treatment for recurrence within 4 weeks.
Study results in premature infants with ROP treated with bevacizumab
A successful outcome was reported in 100% of the eyes receiving the 0.016 mg dose and 0.008 mg dose, 90% of the eyes receiving the 0.004 mg dose but only 74% of the eyes receiving the 0.002 mg dose, suggesting that 0.004 mg should be the lowest dose to be prescribed.
The authors said that further studies are needed to assess whether the efficacy of low-dose bevacizumab is sustained over time and to investigate the effects on plasma VEGF levels and peripheral retinal neovascularization in comparison with the standard higher doses and with laser photocoagulation.
“We report outcomes to only 4 weeks, but we will follow up these infants and report recurrence rates and 2-year outcomes,” they wrote. – by Michela Cimberle
Disclosure: Wallace reports he received grants from the National Eye Institute during the conduct of the study and has a patent for ROPtool (FocusROP) with royalties paid. Please see the study for all other authors’ relevant financial disclosures.