drugset / Trial / NCT05033106

Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity

NCT05033106

Phase 3 Unknown 36 enrolled Zagazig University Cairo University · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.

Timeline

Start
2020-09-01
Primary completion
2022-09-01
Completion
2022-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 0.625 mg Intravitreal
Comparator Ranibizumab Monoclonal antibody 0.25 mg Intravitreal