Dexamethasone eye drops show promise in type 1 retinopathy of prematurity

Treatment with dexamethasone eye drops is safe and may reduce the need for invasive treatment in preemies with type 1 retinopathy of prematurity (ROP), according to the DROPROP study.

DROPROP included 100 infants born before 30 weeks of gestation (mean gestational age at birth 25.1 weeks, 42 percent female, mean birthweight 712.9 g) who had severe ROP. These infants were randomly assigned to receive dexamethasone eye drops (1 mg/mL; n=50) or placebo (saline; n=50). One drop was administered every day or every other day for up to 12 weeks.

The primary outcome was progression to type 1 ROP requiring invasive treatment. Adverse events were also monitored.

In the intention-to-treat population, the primary outcome occurred in 20 percent of infants in the dexamethasone group vs 38 percent in the placebo group (adjusted odds ratio [aOR], 0.44, 95 percent confidence interval [CI], 0.17–1.12; p=0.08).

In the per-protocol population, type 1 ROP occurred in 18.8 percent of infants in the dexamethasone group vs 38.8 percent in the placebo group (aOR, 0.40, 95 percent CI, 0.15–1.05).

Adverse events were similar between the dexamethasone and placebo groups.

Although the result for the primary outcome was not significant, the present data suggest that dexamethasone eye drops may represent a noninvasive strategy to reduce the need for invasive treatment, researchers said.