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Dexamethasone may reduce severe ROP
Topical treatment numerically reduced progression to treatment-requiring retinopathy of prematurity in a randomized trial, although the primary endpoint was not met.
To evaluate the effect of topical dexamethasone on the progression to treatment-requiring retinopathy of prematurity (ROP) in extremely preterm infants.
Approach:
Study Design: A double-masked randomized clinical trial (DROPROP) enrolling 100 infants born before 30 weeks' gestational age across six university hospitals and eight county hospitals in Sweden from 2022 to 2025.
Intervention: Infants with prethreshold ROP were assigned to receive either topical dexamethasone (1 mg/mL) or placebo for up to 12 weeks.
Primary Outcome: Progression to type 1 ROP requiring invasive treatment, analyzed by intention-to-treat and adjusted for gestational age and study site.
Secondary Outcomes: Included time to treatment-requiring disease, recurrence following treatment, and safety outcomes.
Key Findings:
20% of infants receiving dexamethasone developed treatment-requiring type 1 ROP compared to 38% in the placebo group, indicating a 47% relative risk reduction, although the difference did not reach statistical significance.
No significant differences were observed in time to progression to type 1 ROP or recurrence following treatment between groups.
Adverse event rates were similar between dexamethasone and placebo groups, with no clinically significant difference in intraocular pressure.
Interpretation:
The trial did not meet its primary endpoint, and the findings were not statistically significant.
Limitations:
The trial may have been underpowered due to lower than anticipated treatment effect and placebo event rate.
Seven infants received invasive treatment despite not meeting criteria for type 1 ROP, which may have influenced treatment estimates.
Conclusion:
The findings suggest the need for further investigation to confirm results and identify potential subgroups of infants who may benefit from dexamethasone.
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