Abstract
Purpose The purpose of this study was to evaluate the impact of intravitreal ranibizumab (IVR) introduction on treatment patterns for retinopathy of prematurity (ROP) and the incidence of severe complications, including retinal detachment (RD), in a real-world setting. Methods We retrospectively analyzed 785 infants born at ≤1800 g or ≤34 weeks of gestation between January 2016 and December 2022 at two tertiary hospitals in Japan. IVR (0.2 mg/0.02 mL) was introduced in August 2020 at Tohoku University Hospital and in December 2019 at Miyagi Children's Hospital. Infants meeting Early Treatment for Retinopathy of Prematurity (ETROP) criteria received either retinal photocoagulation (RPC), IVR, or both, depending on the treatment era. Severe cases with RD (stage 4A or higher) were managed with scleral buckling or vitreous surgery as needed. Results Of the 472 infants treated prior to IVR introduction, 41.3% were extremely low birth weight (ELBW), comparable to 41.5% among the 291 infants treated after IVR introduction. The proportion undergoing RPC significantly decreased from 9.7% to 5.4% following IVR availability (p=0.03). Notably, the incidence of RD dropped from 2.1% to 0% after IVR introduction (p=0.01), despite no significant change in ELBW distribution. Conclusion The introduction of IVR has markedly shifted ROP treatment paradigms, reducing reliance on RPC and completely eliminating RD in our cohort. IVR offers a targeted, less destructive therapeutic alternative, potentially preserving retinal architecture and improving long-term visual outcomes. While these findings are encouraging, prospective studies are needed to further assess the safety and efficacy of IVR in this vulnerable population.