First Author: E.Alyamaç Sukgen TURKEY
Co Author(s): Y. Kocluk
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Retinopathy of prematurity (ROP) is the most important cause of preventable blindness in childhood. The standard treatment of ROP is laser photocoagulation of the avascular retina. However, in posterior zone-affected severe ROP cases, in contrast to the low efficacy and high ocular morbidity of laser therapy, positive anatomical results have been obtained with intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents. The purpose of this study was to compare the results of ranibizumab and aflibercept (two FDA-approved and licensed anti-VEGF agents) treatment in infants with treatment-requiring retinopathy of prematurity (ROP) in the posterior zone.
This single-centre, retrospective study compared the results of ranibizumab and aflibercept treatment in infants with treatment-requiring retinopathy of prematurity (ROP) in the posterior zone.
This single-centre, retrospective study was done by scanning the records of the infants who were treated between October 2013 and October 2016 in a tertiary centre for screening and treatment of ROP. The decision to treat of infants with ROP was made according to criteria recommended by the Early Treatment for Retinopathy of Prematurity (ETROP) Study. The location of the disease was defined according to the criteria of the International Classification of Retinopathy of Prematurity. Anti-VEGF treatment was recommended in infants who had treatment-requiring ROP in the posterior zone (zone1 or posterior zone 2). Infants who were administered ranibizumab or aflibercept as initial treatment and had completed at least one year of corrected age were included in this study. Patients who received different anti-VEGF agents or different diagnoses were excluded. Additionally, patients who had been administered any previous treatment (laser, cryotherapy, surgery or other anti-VEGF agents) were excluded. Follow-up examinations after treatment were performed on the first day, first week, and then bi-weekly until vascularization of the peripheral retina reached zone III, then monthly for one year postoperativly. The patients were evaluated in terms of regression, progression or recurrence of the disease, vascularization of the peripheral retina and refractive status.
Sixty-two eyes of 31 infants who received ranibizumab treatment (Group-1) and 40 eyes of 20 infants who received aflibercept treatment (Group-2) were enrolled in the study. Recurrence of ROP developed in 30 eyes in Group-1 and six eyes in Group-2. The reccurence was observed at postmenstrual (PM) week 42.64±1.508 in Group-1 and PM week 51.16±10.71 in Group-2. Vascularization of the peripheral retina had been completed at PM week 59.68±9.91 in Group-1 and at PM week 68.36 ± 7.02 in Group-2. After a single-dose treatment there was a significant statistical difference between the ranibizumab and aflibercept groups in the rate of ROP recurrence, the time of recurrence and the time of completed peripheral retina vascularization (p = 0.001, p = 0.00, p = 0.00). There were avascular areas in the peripheral retina of 10 eyes in each group at one year of corrected age; however, this was not statistically signiﬁcant (p= 0.320). After cycloplegic examinations, the obtained spherical equivalent values were 0.58 dioptria in the ranibizumab group and 0.46 dioptria in the aflibercept group (p= 0.39).
Although both ranibizumab and aflibercept are effective therapy for treatment of ROP and they have similar effects in the early period, they may lead to different outcomes in the late period because of differences in their pharmacokinetics. So, more and much earlier recurrence can be seen with ranibizumab treatment. Further studies are needed to obtain ideal options for the treatment of ROP.