Promising results and limited side effects.
At the 33rd ASRS (American Society of Retina Specialists) Congress, Vienna 10-14 July 2015, data from a long-term study were presented, demonstrating a good safety profile in the intravitreal use of bevacizumab for the treatment of ROP (Retinopathy Of Prematurity) in infants born preterm.
The 9-year study was carried out in Mexico, Chile and India, and focused on the occurrence of side and systemic effects. 418 eyes of 262 infants were examined. The average birth weight was 1.338 kg (with a range from 600 g to 1.8 kg), the average age at birth was 30 weeks, and the average age at the start of treatment was 36 weeks.
Dr. Maria Martinez-Castellanos stated that 47 systemic adverse events were reported, including three deaths unrelated to bevacizumab treatment: the first was due to an infection, the second to a brain operation and the last to a blood transfusion.
Twenty-two infants presented with delays in psychomotor development, six with respiratory distress syndrome, nine with intraventricular haemorrhage.
Seventy-three local adverse events were reported, which included 68 eyes with subconjunctival haemorrhages, 14 eyes with a persistent avascular situation in the retinal periphery, six eyes with a self-limiting vitreous haemorrhage, three eyes with a peripheral avascular fibrous membrane, one eye with a subretinal haemorrhage and one eye with a rhegmatogenous retinal detachment.
As Dr Martinez-Castellanos pointed out, most of the adverse events were either due to the administration technique (the intravitreal injection) or to pre-existing conditions. In fact, in cases where the retina was already partially detached, it detached further. As far as the systemic events are concerned, it is not possible to state with certainty whether they are related to bevacizumab or to prematurity per se.
These comforting data are to be read in conjunction with the publication in BMC Ophthalmology of March of a study that confirmed the efficacy of intravitreal ranibizumab therapy in the treatment of ROP stage III plus.
Stage III ROP is characterised by the development of abnormal blood vessels in the retina, which grow towards the inside of the eye, rather than on the retinal surface, as would be normal. Some infants with stage III ROP improve spontaneously, without any treatment, and eventually show normal development of visual function. When, on the other hand, the preterm birth condition evolves towards 'plus disease', retinal blood vessels become larger and more convoluted, which is associated with an aggravation of the disease. In these cases, therapeutic intervention has a good chance of preventing retinal detachment. In this study, a case of upper airway infection with suspected nasopharyngitis was reported as a side effect of ranibizumab. In addition, an elevation of introcular pressure after intravitreal injection was reported as a frequent complication.
Further future studies may give even clearer and more definite indications on the safety and efficacy of anti-VEGFs in the treatment of ROP.
Dr. Carmelo Chines
Direttore responsabile
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