Comparison of intravitreal injection of ranibizumab versus bevacizumab for treatment of type 1 and aggressive retinopathy of prematurity in rural Egypt. A randomized clinical trial

OBJECTIVE: The objective of this study is to evaluate the efficacy of intravitreal ranibizumab (IVR) monotherapy compared with intravitreal bevacizumab (IVB) monotherapy for treatment of type 1 and aggressive retinopathy of prematurity (ROP) in rural Egypt. METHODS: 36 eyes of 18 infants with bilateral aggressive or type 1 ROP were recruited between September 2020 and September 2022. Mean follow-up duration was 16.53 months. IVB was injected in the right eye and IVR in the left eye, rescue injection of the same initial anti-vascular endothelial growth factor (VEGF) in case of ROP reactivation. Outcome measures included regression achieved either by single injection or multiple injections or additional laser therapy at 55 weeks’ postmenstrual age (PMA), recurrence of ROP, total retinal vascularisation time and complications. RESULTS: Initial regression of ROP within 1 week occurred in 11/18 eyes (61.1%) in bevacizumab group and 15/18 eyes (83.3%) in ranibizumab group (p=0.137). Primary outcome measure was achieved in 14/18 eyes (77.8%) and 16/18 eyes (88.9%) in bevacizumab and ranibizumab groups, respectively (p=0.658). Late reactivation requiring retreatment with anti-VEGF was encountered in 4/18 eyes (22.2%) and 1/18 eyes (5.6%) in bevacizumab and ranibizumab groups, respectively (p=0.338). Peripheral laser therapy on the avascular retina was done in 3/18 eyes (16.7%) in each group at mean of 55.67 weeks' PMA. CONCLUSION: Bevacizumab and ranibizumab proved to be effective regarding regression of acute ROP and continuing peripheral retinal vascularisation. Higher proportion of reactivation with bevacizumab, however, clinically non-significant. Laser therapy can be postponed to reduce its complications. TRIAL REGISTRATION NUMBER: NCT05033106.