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Fernando Molle, Domenico Lepore, Antonio Baldascino, Carmine Angora, Lorenzo Orazi, Monica M. Pagliara, Carmen Giannantonio, Velia Purcaro, Patrizia Papacci, Costantino Romagnoli; Intravitreal Injection of Bevacizumab Vs. Conventional Laser Treatment in Type 1 ROP. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3143.
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to evaluate structural outcome of Intravitreal injection of Bevacizumab (IVB) for type I ROP compared to conventional laser treatment.
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 31st July ’10 7 babies (14 eyes) with a mean BW of 606.7gr (range 450-840) and a mean GA of 25.8wks (range 23-29) were enorolled. At the time of treatment the first eye was randomized for intravitreal injection of 0.5mg di Avastin in a 0.02 ml BS solution; the second eye, used as control, was randomized for conventional laser photoablation of the peripheral avascular retina. Binocular indirect ophthalmoscopy (BIO) and digital Retcam were performed before treatment and every 3 days while digital FA at treatment and every 2 wks until discharge. After discharge from NICU, BIO was performed every 2 wks until 52nd wk of PMA and then monthly until 1 years of age. Babies underwent FA, cyclopegic refraction and IOP measurement at 6 month and at 1 year of age under general anaesthesia.
one eye of the laser group progressed to stage 4b and therefore results considered unfavourable according to CryoROP. Remaining 6 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. Furthermore all but one eyes showed some fluorangiographic abnormalities either at the periphery or at the posterior pole.
the IVB seems to be able to stop the progression to retinal detachment. Some concerns for the use of IVB in type 1 zone 1 arise from the FA study. Long term follow-up is needed to evaluate the effect of bevacizumab on panretinal development.
Clinical Trial: :
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