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De-escalating dose of bevacizumab may be effective in treating ROP
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NEW ORLEANS — A dose of intravitreal bevacizumab as low as 0.031 mg was successful in treating acute, severe retinopathy of prematurity in a small cohort of infant patients, a speaker said here.
“Doses as low as 5% of what was used and considered the standard dose in the BEAT-ROP study were successful in nine out of nine infants, although some infants required additional treatment,” David K. Wallace, MD, MPH, said at the American Academy of Ophthalmology meeting.
Wallace and colleagues conducted a dose de-escalation study of 10 to 14 infants with type 1 ROP. Each study eye received an initial dose of 0.25 mg of Avastin (bevacizumab, Genentech) and a small dose each subsequent week over the 4-week study. At week 2 patients received a 0.125 mg dose, at week 3 patients received a 0.063 mg dose, and at week 4 patients received a 0.031 mg dose, he said.
All doses resulted in reduced plasma VEGF levels in each patient, and the lower doses do not seem to have less effect on the plasma VEGF levels, Wallace said.
He said the study will continue to go lower with each dose until the effects are no longer significant. – by Robert Linnehan
Reference:
Wallace DK. A phase 1 dosing study of intravitreal bevacizumab for retinopathy of prematurity: 6-month follow up. Presented at American Academy of Ophthalmology annual meeting; Nov. 11-14, 2017; New Orleans.
Disclosure: Wallace reports he has patents and received royalties with FocusROP and receives grant support from the National Eye Institute.
Perspective
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R.V. Paul Chan, MD, FACS
This study by Wallace and the Pediatric Eye Disease Investigator Group helps give us a better understanding of what the minimum dose of bevacizumab could potentially be for treating ROP.
The Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity (BEAT-ROP) study and other investigators have published on using 0.625 mg of bevacizumab for ROP, but over the past decade there was still the unanswered question of whether or not a smaller concentration of anti-VEGF can still be effective. One of the most important concerns is if there will be significant systemic VEGF suppression by giving too much drug intraocularly. Therefore, if you can give a lower dose that is effective, this could potentially lessen any systemic sequelae. So, what is the optimum dose that we can give these children?
A notable result of this study by Wallace and colleagues is that the amount of bevacizumab shown to be effective was so small, 0.031 mg compared to the 0.625 mg used by others. Therefore, should we start using a lower dose if we are going to use these drugs more frequently? This is still to be determined.
Although this study starts to help us answer the questions of what the lowest effective dose of anti-VEGF may be, the study has a small sample size and we still need longer term data in terms of the outcomes for these children.
Another major question is determining what anti-VEGF agent to use for ROP. There are a lot of questions regarding what drug is the best drug for this condition. Bevacizumab, ranibizumab, aflibercept, pegaptanib and conbercept are all off-label for use in the treatment of ROP. What will the results of the Ranibizumab Compared With Laser Therapy for the Treatment of Infants Born Prematurely With Retinopathy of Prematurity (RAINBOW) study show? Also, will it be necessary to have a study comparing the outcomes of different anti-VEGF agents for ROP, similar to the Comparison of AMD Treatment Trials (CATT)? Currently, there are no trials comparing the effectiveness of one anti-VEGF agent to another for ROP.
Overall, this study by PEDIG starts to shed some light on the question of the lowest effective dose of bevacizumab for ROP. These data will likely help guide the designs of future clinical trials.
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