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R. Reddy, F. Recchia, S. Steele, P. Lu; Systemic Adverse Events Among Infants With Retinopathy of Prematurity (rop) Treated With Intravitreal Bevacizumab: Determination of a Statistically Valid Cohort. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5228.
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A growing body of clinical evidence shows encouraging results following intravitreal injection of the anti-VEGF monoclonal antibody bevacizumab (IVB) in infants with treatment-requiring ROP. Significant concerns remain, however, regarding systemic adverse events (AE) of VEGF inhibition in a growing neonate.This study was conducted to: (1) determine the incidence of AEs among infants with aggressive posterior ROP (AP-ROP) treated with adjunctive (IVB); (2) to calculate, for the purpose of clinical trials, a sample size sufficient to detect a significant difference in AEs between patients treated with IVB and those treated with laser photocoagulation.
Single-center, comparative cohort study. Records of patients with ROP treated by a single surgeon between 1-1-04 and 12-31-08 were reviewed and separated into 3 groups according to disease and treatment: (1) AP-ROP treated with laser + IVB; (2) AP-ROP treated with laser; (3) threshold ROP treated with laser. Outcome measures were: laser time; rate of retinal detachment (RD); incidence of selected AE (sepsis, ventilator support, additional surgeries, hypertension, necrotizing enterocolitis, and mortality). Statistical analysis was done using the Wilcoxon rank-sum test, the Fisher’s exact test, and the Chi-squared test.
44 infants were divided as follows: 5 in group 1, 9 in group 2, and 30 in group 3. IVB was used prior to laser only in eyes with severe anterior segment vascular congestion precluding full laser treatment. Demographic, gestational age at birth, and maternal factors (diabetes,age) were similar among the 3 groups. Laser time was shorter in group 3(68 min), when compared to groups 1(90 min, p=.0001) and 2(92min, p=.004). Mortality rate was highest in group 1(40%) compared with groups 2(20%) and group 3(7%) (p = 0.231). The incidence of RD was lowest in group 3 (40% vs. 40% vs. 3%, p=0.004). There were no differences in incidence of any systemic AEs. The sample size needed for an effect size of 0.5 and a power of 0.9 was calculated to be 17 patients per cohort.
The incidence of RD was consistent with that expected for the cohorts treated. There were no significant differences in mortality or selected systemic AEs among infants with or without AP-ROP and treated with laser alone or with adjunctive IVB. Based on the incidence of AEs in this study, a clinical trial would require at least 17 patients per group in order to detect a significant difference in systemic AEs.
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