[Review of clinical trials in retinopathy of prematurity : Current state and future perspectives].

BACKGROUND: The treatment of retinopathy of prematurity (ROP) has gained a new dynamic since the introduction of anti-vascular endothelial growth factor (VEGF) therapy. This review summarizes clinical trial data in order to aid informed decision-making.

METHODS: In this article, pivotal clinical trials are summarized and discussed with regard to their implications for ROP therapy.

RESULTS: The longest follow-up phase exists for children treated in the CRYO-ROP study, which used retinal cryocoagulation to treat ROP. Based on results of the ETROP study and others, retinal laser therapy has replaced cryotherapy as standard of care. For anti-VEGF treatment, three controlled clinical trials exist to date: BEAT-ROP, CARE-ROP, and the PEDIG study. Combined, these studies demonstrate efficacy of anti-VEGF in treating acute ROP. However, they also emphasize the risk of (late) recurrences and the largely unsolved questions regarding choice of drug and dose as well as long-term safety.

CONCLUSION: Treatment of ROP remains a highly individual decision in which many variables need to be considered. The data discussed in this article can help in decision-making and emphasize the unique characteristics of the available therapeutic approaches, in particular regarding postoperative follow-up.