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.
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.
Study population & Sample size Infants with Type 1 ROP (affecting both eyes) screened at neonatal intensive care unit (NICU) of Cairo University.
The sample size is calculated to be 36 eyes of 18 infants using open Epi confidence total 95%, power of the study 80% according to the following : the mean SD of axial length of patients with stage 3 ROP using bevacizumab versus ranibizumab (20.3 1.16 versus 19.4 ).
This is a prospective, comparative, interventional non inferiority study.
|Condition||Retinopathy of Prematurity Both Eyes|
|Clinical Study Identifier||NCT05033106|
|Last Modified on||9 September 2021|
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