Evaluation of treatment of retinopathy of prematurity by intravitreal injection of Ranibizumab: a clinical trial

Objectives Evaluation of treatment of type-I retinopathy of prematurity (ROP) detected by early screening of preterm infants by intravitreal injection of Ranibizumab. Background Retinopathy of prematurity is a childhood-blindness disease. Considering Ranibizumab might have a better safety profile for preterm infants, some authors shifted IVB to intravitreal injection of Ranibizumab to treat ROP. Patients and methods A clinical trial was performed between January 2021 and May 2022 in the neonatal ICU and Department of Ophthalmology, Menoufia University on 131 preterm infants. Type-I ROP cases were diagnosed and treated with intravitreal injection (IVI) of antivascular endothelial growth factor Ranibizumab 0.25 mg/0.025 ml. Injection was done 1.5 mm posterior to limbus. Both eyes were injected in the same sitting with different sterile sets. Follow-up was performed after 1 day to IVI, 1 week, and then according to stage of ROP. Results Thirty patients developed ROP severe enough to require intervention. Five (38.50%) cases had stage 2, five (38.50%) cases had stage 3, and three (23.10%) cases had aggressive posterior retinopathy of prematurity. The mean gestational age for type-1 ROP cases was 30 ± 1.8 weeks (28–35 weeks), mean birth weight was 1.3 ± 0.3 (0.950–1.6), and mean postmenstrual age was 34 ± 2. The mean follow-up time was 14 ± 1.37 months (range, 12–24 months). The efficacy of IVI of Ranibizumab in our study is 21 (80.7%) of 26 and recurrence requiring treatment occurred in five eyes from 26 (19.2%) eyes. Conclusion Single dose of Ranibizumab improving type-I ROP as regression of plus disease and newly formed vessels, and allows for continued vessel growth into the peripheral retina.