Reduction of retinopathy of prematurity in extremely low gestational age newborns treated with recombinant human Cu/Zn superoxide dismutase.

Background: Reactive oxygen species have been implicated in the pathogenesis of retinopathy of prematurity (ROP). Extremely low gestational age (GA) newborns (ELGANs) have the highest risk of ROP and might benefit most from treatment with antioxidants.

Objectives: To determine whether recombinant human Cu/Zn superoxide dismutase (rhSOD) decreases the incidence or severity of ROP in ELGANs.

Methods: A previous multicenter trial of intratracheal rhSOD for prevention of bronchopulmonary dysplasia randomized 302 preterm infants to receive intratracheal rhSOD or placebo at birth and every 48 h for 1 month. An analysis of the incidence and severity of ROP was performed in ELGANs.

Results: The risk of ROP increased with decreasing GA. Within the entire cohort, no significant differences in ROP were found in the placebo versus rhSOD groups. Subgroup analysis on infants born at <26 weeks (n = 72) revealed a 22% reduction in ROP from 85% (placebo) to 66% (rhSOD) (p = 0.06). In subjects born at <25 weeks (n = 24), ROP was reduced by 53% from 85% (placebo) to 40% (rhSOD) (p = 0.03). ROP severity above stage 2 was found in 42% of placebo-treated infants but only 25% of rhSOD-treated subjects with ROP.

Conclusions: This post hoc analysis suggests that rhSOD reduces the risk of developing ROP in ELGANs, although further studies are required to confirm this observation.