Abstract
Purpose:
The recent usage of intravitreal bevacizumab injection (IVB) to treat retinopathy of prematurity (ROP) has led to questions regarding the systemic absorption of bevacizumab and its potential long-term side effects. We performed a prospective clinical study to test the hypothesis that IVB-treated infants have the same or superior long-term vision and neurodevelopmental outcomes when compared to laser-treated infants.
Methods:
A cohort study of infants with severe ROP who were treated with 0.625 mg IVB injection or laser from 2010 to 2012 were enrolled to evaluate the long-term efficacy and safety of IVB versus laser treatment. Twenty one patients (41 eyes) were treated with IVB and 15 patients (29 eyes) were treated with laser. The main outcome measurements at 1 and 3 years chronological age were cycloplegic refraction, visual acuity, body weight, height, and the developmental quotients (DQ) of gross motor, visual-motor problem solving, and language. Two-tailed student’s t-tests were used to compare the group means of the IVB-treated and laser-treated groups.
Results:
At 1 year of age, the mean spherical equivalent was -0.05 ± 3.01 diopter (D) in the IVB-treated group and -3.48 ± 4.23 D in the laser-treated group (p=0.02). At 3 years of age, the mean spherical equivalent was -3.56 ± 4.04 D in the IVB-treated group and -8.61 ± 4.88 D in the laser-treated group (p=0.05). The mean visual acuity in LogMar at 3 years of age was 0.69 (SD 0.31) and 0.86 (SD 0.35) in the IVB- and laser-treated groups, respectively (p=0.1). There was an increase in gross motor, visual-motor problem solving, and language developmental quotients (DQ) over time in both groups. However, the changes were not significant (p=0.1 to 0.7). There were no significant differences in any neurodevelopmental sub-domains, body weight, or height between the two groups (p=0.3).
Conclusions:
The results of the study are consistent with our hypothesis that in severe ROP, IVB-treated infants have a lower degree of myopia when compared to laser-treated infants. However, the two treatment groups were found to have similar neurodevelopmental outcomes.