Intravitreal ranibizumab in aggressive retinopathy of prematurity compared with type 1 retinopathy of prematurity in Egyptian preterm infants (non-randomized clinical trial)

Abstract Purpose: To assess the efficacy of intravitreal ranibizumab (IVR) monotherapy in type 1 retinopathy of prematurity compared to aggressive retinopathy of prematurity (A-ROP) in Egyptian preterm infants. Methods: A-ROP group included 18 eyes of 15 infants and type 1 ROP group included 19 eyes of 15 infants who were recruited between November 2020 and November 2022. Both groups received IVR. Rescue IVR injection was given for reactivation. Outcome measures included regression achieved by single or multiple injections, recurrence of ROP, retinal vascularization time, need for laser photocoagulation and complications. Mean follow-up duration was 11.44 and 13.95 months for A-ROP and type 1 ROP groups, respectively. Results: Regression of ROP by single injection at 55 weeks’ PMA was achieved in 11/18 eyes (61.1 %) in A-ROP and 19/19 eyes (100%) in type 1 ROP group (P= 0.003). 4 /18 eyes (22.2%) in the A-ROP group developed late reactivation which necessitated rescue injection. Vascularization reached zone III in 9/18 eyes (50%) at 52.59 ± 3.89 weeks' PMA in A-ROP group, and all eyes in type 1 ROP group (P < 0.001). Indirect laser photocoagulation on peripheral avascular retina was done in 5/18 eyes (27.8 %) in A-ROP group at mean of 59.2 weeks' PMA (P=0.008). No laser was needed in type 1 ROP. Conclusion: Ranibizumab has proved to be effective regarding prompt initial regression of active ROP in type 1 ROP and A-ROP. Higher proportion of reactivation and rescue injection was significantly detected in A-ROP group than type 1 ROP group. Trial registration number NCT05701124