Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity
Status:
Completed
Trial end date:
2022-11-20
Target enrollment:
Participant gender:
Summary
Despite advances in the neonatal intensive care units, retinopathy of prematurity (ROP) has
become a common reason for blindness and visual disabilities in premature infants so that it
accounts for about 5% and 30% of such complications in developed and developing countries.
The pathophysiology of ROP is multifactorial. Supplemental oxygen demand and lower
gestational age (GA) and birth weight (BW) are among the major risk factors for the
occurrence and progression of ROP.
Anti-vascular endothelial growth factor (anti-VEGF) agents are a promising modality of
treatment for ROP, as laser therapy is associated with disadvantages such as complications
from undertreatment or overtreatment, anterior segment burns, hemorrhage, or ischemia, and
potentially higher rates of myopia. Ranibizumab is the first approved anti-VEGF treatment for
the management of retinopathy, and is a promising alternative to laser therapy.
Ranibizumab is a humanized monoclonal recombinant antibody fragment with a shorter half-life
and less systemic toxicity than bevacizumab. Its binding affinity is nearly tenfold that of
bevacizumab.
The plasma half-life of bevacizumab is 17-21 days, while that of ranibizumab is 3 days.
Greater systemic absorption of bevacizumab is thought to lead to greater systemic suppression
of VEGF. These data may explain the better safety profile of ranibizumab. Type I ROP is
defined as any stage of ROP with plus disease in zone I, stage 3 ROP in zone I and stage 2 or
3 ROP with plus disease in zone II . The hallmark of Aggressive-ROP (previously known as
Aggressive posterior-ROP) is rapid development of pathological neovascularization and severe
plus disease without progression being observed through the typical stages of ROP. It may
occur in larger preterm infants and beyond the posterior retina.
The aim of this prospective study is to compare the efficacy of intravitreal ranibizumab for
type 1 ROP and A-ROP as regard acute ROP regression, recurrence profile, peripheral retinal
vascularization and the need for further ablative therapy.