Researchers in Taiwan who wanted to evaluate neurodevelopmental outcomes in infants with premature retinopathy (ROP) after intravitreal bevacizumab (IVB) found that the risk of severe neurodevelopmental impairment (sNDI) did not increase in IVB-treated patients .
ROP is a leading cause of blindness in children worldwide. Laser photocoagulation was the most common treatment for high risk ROP. However, the recent Bevacizumab Eliminates the Angiogenic Threat of ROP study concluded that IVB, an anti-vascular endothelial growth factor (anti-VEGF) agent, performed better in type 1 ROP patients compared to laser treatment, according to researchers . However, this treatment is not without its drawbacks, including uncertainty about the long-term systemic side effects of its use in premature infants.
To study the effect of IVB therapy on this population, researchers performed a meta-analysis of relevant published research. To be included in the analysis, comparative studies of ROP patients had to include IVB as a treatment option, include a control group that was not receiving bevacizumab, and report at least 1 neurological development outcome such as sNDI, Bayley. III Composition Values or Cerebral Palsy (CP). The primary result was sNDI, where the odds ratio (OR) was calculated. Secondary outcomes were mean differences (MDs) for cognitive, language, and motor scores (Bayley III) and OR for cerebral palsy. The quality of the evidence was assessed using the GRADE approach.
The results published in Ophthalmology suggest that IVB treatment did not significantly increase the risk of sNDI or CP, and that cognitive function and speech performance after about 2 years of corrected age in infants undergoing IVB treatment, and were similar to their corresponding 300 controls. A slightly more favorable motor score was found in the control group compared to the IVB group. However, the clinical significance of this difference (3.7) is unclear, according to researchers.
More than 700 infants from 8 different studies were included in the analysis. The weighted OR for sNDI in the IVB group was 1.39 (95% CI: 0.98 to 1.97). The weighted MDs were -2.10 (95% CI: -4.94 to 0.74), -1.32 (95% CI: -4.65 to 1.99) and -3.66 (95% CI : -6.79 to -0.54) for cognitive, linguistic and motor values in Bayley III. The OR for CP was 1.20 (95% CI: 0.56 to 2.55). No differences were observed between the preset subgroups, which included laser-controlled ROP infants and ROP infants who did not require treatment. The quality of the evidence was rated as low (sNDI and all Bayley III scores) to very low (CP).
The researchers identified several limitations with their study, including selection biases in the studies included in the analysis. In fact, only one study included randomly assigned treatments. Second, the analysis only included a small number of studies. Third, the GRADE analysis of the team’s evidence suggests that the quality is poor. In addition, the definitions of sNDI differed slightly in the studies analyzed, and 4 of the studies did not report the dose of bevacizumab administered. Finally, other anti-VEGF drugs, including ranibizumab and aflibercept, are viable treatments for type 1 ROP.
The researchers recommend further research to clarify the effects of anti-VEGF therapy on brain development in premature babies.
Tsai CY, Yeh PT, Tsao PN, et al. Neurodevelopmental results after bevacizumab treatment in premature retinopathy – a meta-analysis. Ophthalmology. November 2020. doi: 10.1016 / j.ophtha.2020.11.012.
This article originally appeared on Ophthalmology Advisor