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Low-dose bevacizumab may be effective, safer for ROP

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NASHVILLE, Tenn. — Bevacizumab doses that are a fraction of those studied in the BEAT-ROP trial may be successful in treatment of type 1 retinopathy of prematurity, according to a speaker here.

“The 0.625 mg dosage, which is commonly used, is certainly a reasonable starting point, but it’s probably much more than is necessary,” David K. Wallace, MD, MPH, told colleagues at the American Association for Pediatric Ophthalmology and Strabismus meeting, where he reported results of a phase 1 dose de-escalation study.

David K. Wallace

“We know that after intravitreal injection, it reaches the systemic circulation and we know there are large, persistent reductions in serum VEGF. We also know that VEGF is necessary for normal development of the tissues of the body, including the normal development of the retina. There is particular concern about the possible increased risk of neurodevelopmental disability,” he said.

In the study, groups of 10 to 14 infants with type 1 ROP in one or both eyes with no previous treatment were treated at one of the following doses: 0.25 mg, 0.125 mg, 0.063 mg and 0.031 mg, the lowest dose, which is 5% of that studied in BEAT-ROP.

Avastin (bevacizumab, Genentech/Roche) is an off-label use of the drug for the ROP indication.

Success or failure at 4 weeks was the primary outcome, with success defined as improvement by 3 to 5 days and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.

For all type 1 ROP study eyes, treatment was successful in 11 of 11 eyes at the 0.25 mg dose, 14 of 14 at the .125 mg dose, 21 of 24 at 0.063 mg dose (this level of dosing was repeated in a second group) and nine of nine eyes in the 0.031 mg group.

“The [Data Safety and Monitoring Committee] had a huge role in this study,” Wallace said. “After every group of infants were treated, the DSMC reviewed the outcomes and decided whether we could go to the next dose, whether we needed to repeat it, whether we needed to increase it, or whether we needed to end the study.”

After the first dose, the investigators were masked to the dose amount used. In all, 17 investigators at nine sites treated 61 infants; 58 infants completed 4-week exams. Mean birth weight was 709 g, mean gestational age was 24.9 weeks, and 93% of the infants had bilateral type 1 ROP.

All doses tested reduced plasma VEGF levels, and lower doses tested to date do not seem to have less effect on plasma VEGF levels, Wallace said.

“Our sample size was small. The true success rate may be much lower,” Wallace said, adding, “We ultimately want to assess effectiveness and systemic safety in a larger long-term trial.” – by Patricia Nale, ELS

Reference:

Wallace DK. Phase 1 dose-finding study of bevacizumab for retinopathy of prematurity. Presented at: American Association for Pediatric Ophthalmology and Strabismus annual meeting; April 2-6, 2017; Nashville, Tenn.

Disclosure: Wallace reports receiving funding from the National Eye Institute.