medwireNews: FIREFLEYE next study findings support the use of aflibercept injection to achieve disease control and appropriate visual function in extremely low birthweight and preterm children with severe acute-phase retinopathy of prematurity (ROP).
Intravitreal aflibercept showed “favorable efficacy” and was “well tolerated through 2 years of age,” report Andreas Stahl (University Medicine Greifswald, Germany) and colleagues in JAMA Network Open.
In this interim analysis, the researchers evaluated 2-year ophthalmic and safety outcomes from March 2020 to July 2022 in children across Asia, Europe, and South America who had received treatment for severe acute-phase ROP in the FIREFLEYE trial between 2019 and 2021. The enrolled children were born very or extremely preterm (gestational age ≤32 weeks) or with very or extremely low birthweight (≤1500 g).
Among the 100 enrolled participants (median gestational age, 26 weeks; 53% boys), data were available at 2 years of age for 63 children who were given a single injection of aflibercept 0.4 mg and 32 children who instead received laser therapy. There was no evidence of ROP in 96.8% and 93.8% of these groups, respectively. Similarly, there were no unfavorable structural outcomes over 2 years in 93.9% of the aflibercept group and 94.1% of the laser group.
Four children in the aflibercept group required treatment for ROP complications by the age of 1 year, namely two cases of bilateral retinal detachment that occurred prior to treatment; one child who required bilateral laser therapy for reactivated disease and developed a macular fold in one eye, and a fourth child who experienced incomplete vascularization and retinal neovascularization of both eyes requiring bilateral laser therapy.
No new retinal detachments occurred during the study period, report the investigators.
In terms of functional outcomes, the mean refractive spherical equivalent was –0.6 D for children treated with aflibercept and –1.9 D for those who received laser therapy. Children treated with aflibercept were less likely than those given laser therapy to have high myopia (≥–5.0 D; 7.8 vs 21.7%) or very high myopia (≥–8.0 D; 0.9 vs 13.3%). The majority of children in both groups were able to fix and follow a 5 cm toy with their eyes at 2 years of age (96.7 vs 98.4%).
The proportion of eyes with complete vascularization continued to increase with age in the aflibercept group, at 39.0%, 71.1%, and 80.2% at week 24, 1 year and 2 years of age, respectively; this analysis was not reported in the laser group as “laser scars prevent physiologic vascularization of the peripheral retina,” Stahl et al explain.
Importantly, no relevant differences in treatment-specific growth or neurodevelopmental effects were observed between the two treatment groups.
The authors conclude that follow-up of the FIREFLEYE trial aids “informed decision-making when managing patients with severe acute-phase ROP in very preterm infants” with aflibercept injection therapy, and that “final efficacy and safety data at 5 years of age are expected in 2026.”
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