DROPROP’s 18-point ROP gap: a signal, not a confirmed benefit

In 100 Swedish infants with severe prethreshold ROP, type 1 ROP occurred in 20% with dexamethasone eye drops and 38% with saline, but the adjusted primary analysis crossed the null (OR 0.44, 95% CI 0.17–1.12; P=.08).

THE HOT TAKE

DROPROP randomized 100 Swedish infants born before 30 weeks once severe prethreshold retinopathy of prematurity (ROP) was present. Type 1 ROP requiring laser or anti-VEGF treatment developed in 10 of 50 infants (20.0%) given topical dexamethasone and 19 of 50 (38.0%) given saline. The 18-point raw gap is clinically large; it is not a confirmed treatment effect.

The prespecified analysis adjusted for gestational age and site: adjusted OR 0.44 (95% CI 0.17–1.12; P=.08). The supportive unadjusted OR was 0.41 (95% CI 0.17–1.00), but the adjusted primary analysis is the confirmatory test. Its interval remains compatible with a substantial reduction and with no detectable advantage.

The study hypothesis could not be confirmed.

WHAT DROPROP TESTED

This was a double-masked trial at 6 university and 8 county hospitals in Sweden, enrolling from September 2022 to October 2025. Infants were eligible if born before 30 weeks and they developed severe prethreshold ROP. Mean gestational age was 25.1 weeks and mean birth weight was 712.9 g; all 100 randomized infants had primary-outcome data.