Structural Outcome Of Intravitreal Injection Of Bevacizumab For Type I Rop Compared To Conventional Laser Treatment

Abstract

Purpose: : to evaluate, with a follow up of one year, structural outcome of Intravitreal injection of Bevacizumab (IVB) for type I ROP compared to conventional laser treatment.

Methods: : monocentric Randomized controlled trial started September 1st ‘09 at Neonatal Intensive Care Unit (NICU) of the Catholic University in Rome.All inborn babies with type 1 zone 1 ROP and therefore eligible for laser photoablation following the ETROP indications were included in the study. Until 28th February ’11 thirteen babies (26 eyes) with a mean BW of 698 gr(range 450-710) and a mean GA of 26 wks(range 24,1-29,3)were enorolled. One eye was randomized to receive an intravitreal injection of 0.5mg di Bevacizumab in a 0.02 ml BS solution; the fellow eye received conventional laser photoablation of the peripheral avascular retina.Digital fundus photographs and fluorescein angiography (FA) using RetCam (Clarity,Pleasanton,CA) were performed before treatment.fundus imaging was then performed every 3 days and FA every 2 wks until discharge. After discharge, BIO was performed every 2 wks until 52nd wk of PMA and babies underwent FA, cyclopegic refraction and IOP measurement at 6 month and at 1 year of age under general anaesthesia.

Results: : All but two of the 26 eyes (13 babies) had favourable structural results at the one year follow up. One eye treated with laser progressed to stage 5 complete retinal detachment and another to stage 4a considered unfavourable according to CryoROP. One baby died at three months after treatment. Remaining 10 eyes showed positive results. None of the eyes treatment with a single IVB progressed to retinal detachment but showed an incomplete vascularisation of the peripheral retina and in some cases abnormalities at posterior pole’s (hyperfluorescent lesions, absence of foveal vascular zone). Such lesions were rare in the laser treated eyes.

Conclusions: : the IVB seems to be able to stop the progression to retinal detachment. Although treatment of eyes with zone I type 1 ROP with bevacizumab appears to have a similar effect to that of conventional laser photocoagulation, this report raises concerns about vascular abnormalities and macular development in the bevacizumab group. Long term follow-up is needed to evaluate the effect of bevacizumab on ocular development.

Clinical Trial: : https://eudract.ema.europa.eu 2009-012609-20

Keywords: retinopathy of prematurity • growth factors/growth factor receptors • laser