Results of the BEAT-ROP Clinical Trial

Helen Mintz-Hittner

Purpose: Peripheral retinal ablation with conventional laser therapy (CLT) for retinopathy of prematurity (ROP) is destructive, causes complications, and does not prevent vision loss especially in Zone I cases. Vascular endothelial growth factor inhibitors have shown promise and the primary outcomes of a prospective, randomized, stratified, controlled, multi-center clinical trial are known.

Methods: This clinical trial investigated intravitreal bevacizumab (IVB) monotherapy for Zone I and Zone II posterior Stage 3 with plus disease versus (CLT). RetCam photographs documented retinal appearance pre-treatment, one week and one month post-treatment, and at the primary outcome [54 weeks post menstrual age ~ six months chronological age.] Infants were randomly assigned to IVB (0.625 mg in 0/025 mL) or CLT, bilaterally. Primary outcome failure was incidence of persist or recurrent ROP requiring retreatment or severe treatment complication requiring intraocular surgery.

Results: Primary outcomes on 150 enrolled infants (75 IVB; 75 CLT) are known. Eight infants (seven deaths; 1 protocol deviation) are excluded from the analysis. The mean birth weight was 670 grams and gestational age was 24.4 weeks. Treatment failure occurred in one eye of 2.7% (2/75) of IVB and 9.3% (7/75) of CLT infants and in both eyes 2.7% (2/75) of IVB and 18.7% (14/75) of CLT infants. P-value = 0.001.

Conclusions: IVB monotherapy for ROP is more efficacious with continued development of peripheral inner retinal vessels compared to CLT with permanent destruction of the peripheral retina. Neither ocular nor systemic toxicity attributable to bevacizumab was observed in this clinical trial.