The researchers observed resolution of plus disease and the disappearance of active proliferations soon after treatment. They noted resolution of the ridge and complete resolution of ROP much later.
Two eyes required rescue therapy, one at 14 and one at 17 days. Both these eyes responded well to rescue therapy and had fully resolved ROP at the final visit.
Two infants in each dosage group had recurrences after the 24-day period that were severe enough to warrant retreatment, at a mean of 87 days after the initial treatment for the 0.12-mg dose and 53 days for the 0.20-mg dose. The researchers considered these retreatments as “different in nature” from the rescue treatments because the retreatments were part of a planned anti-VEGF dose titration.
Physiologic vascularisation progressed faster and complete vascularisation was achieved more often with the lower dose.
Mean VEGF levels were not reduced with either dose, and vital signs and growth values were comparable. The number and type of serious adverse events were not different.
“The implications of such-long term systemic VEGF suppression on organ development are unknown,” the researchers wrote. “We hypothesised that ranibizumab may be advantageous in this regard because ranibizumab has a systemic half-life of hours vs. days for bevacizumab.”
They acknowledged limitations to their study, including the small number of patients, a relatively early primary endpoint, and the failure to evaluate lower doses than 0.12 mg.