• Media type: E-Article
  • Title: Assessment of Retinopathy of Prematurity Regression and Reactivation Using an Artificial Intelligence–Based Vascular Severity Score
  • Contributor: Eilts, Sonja K.; Pfeil, Johanna M.; Poschkamp, Broder; Krohne, Tim U.; Eter, Nicole; Barth, Teresa; Guthoff, Rainer; Lagrèze, Wolf; Grundel, Milena; Bründer, Marie-Christine; Busch, Martin; Kalpathy-Cramer, Jayashree; Chiang, Michael F.; Chan, R. V. Paul; Coyner, Aaron S.; Ostmo, Susan; Campbell, J. Peter; Stahl, Andreas; Grundel, Milena; Pfeil, Johanna M; Stahl, Andreas; Bründer, Marie-Christine; Bühler, Anima; Daniel, Moritz; [...]
  • imprint: American Medical Association (AMA), 2023
  • Published in: JAMA Network Open
  • Language: English
  • DOI: 10.1001/jamanetworkopen.2022.51512
  • ISSN: 2574-3805
  • Keywords: General Medicine
  • Origination:
  • Footnote:
  • Description: <jats:sec id="ab-zoi221468-4"><jats:title>Importance</jats:title><jats:p>One of the biggest challenges when using anti–vascular endothelial growth factor (VEGF) agents to treat retinopathy of prematurity (ROP) is the need to perform long-term follow-up examinations to identify eyes at risk of ROP reactivation requiring retreatment.</jats:p></jats:sec><jats:sec id="ab-zoi221468-5"><jats:title>Objective</jats:title><jats:p>To evaluate whether an artificial intelligence (AI)–based vascular severity score (VSS) can be used to analyze ROP regression and reactivation after anti-VEGF treatment and potentially identify eyes at risk of ROP reactivation requiring retreatment.</jats:p></jats:sec><jats:sec id="ab-zoi221468-6"><jats:title>Design, Setting, and Participants</jats:title><jats:p>This prognostic study was a secondary analysis of posterior pole fundus images collected during the multicenter, double-blind, investigator-initiated Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity (CARE-ROP) randomized clinical trial, which compared 2 different doses of ranibizumab (0.12 mg vs 0.20 mg) for the treatment of ROP. The CARE-ROP trial screened and enrolled infants between September 5, 2014, and July 14, 2016. A total of 1046 wide-angle fundus images obtained from 19 infants at predefined study time points were analyzed. The analyses of VSS were performed between January 20, 2021, and November 18, 2022.</jats:p></jats:sec><jats:sec id="ab-zoi221468-7"><jats:title>Interventions</jats:title><jats:p>An AI-based algorithm assigned a VSS between 1 (normal) and 9 (most severe) to fundus images.</jats:p></jats:sec><jats:sec id="ab-zoi221468-8"><jats:title>Main Outcomes and Measures</jats:title><jats:p>Analysis of VSS in infants with ROP over time and VSS comparisons between the 2 treatment groups (0.12 mg vs 0.20 mg of ranibizumab) and between infants who did and did not receive retreatment for ROP reactivation.</jats:p></jats:sec><jats:sec id="ab-zoi221468-9"><jats:title>Results</jats:title><jats:p>Among 19 infants with ROP in the CARE-ROP randomized clinical trial, the median (range) postmenstrual age at first treatment was 36.4 (34.7-39.7) weeks; 10 infants (52.6%) were male, and 18 (94.7%) were White. The mean (SD) VSS was 6.7 (1.9) at baseline and significantly decreased to 2.7 (1.9) at week 1 (<jats:italic>P</jats:italic> &amp;amp;lt; .001) and 2.9 (1.3) at week 4 (<jats:italic>P</jats:italic> &amp;amp;lt; .001). The mean (SD) VSS of infants with ROP reactivation requiring retreatment was 6.5 (1.9) at the time of retreatment, which was significantly higher than the VSS at week 4 (<jats:italic>P</jats:italic> &amp;amp;lt; .001). No significant difference was found in VSS between the 2 treatment groups, but the change in VSS between baseline and week 1 was higher for infants who later required retreatment (mean [SD], 7.8 [1.3] at baseline vs 1.7 [0.7] at week 1) vs infants who did not (mean [SD], 6.4 [1.9] at baseline vs 3.0 [2.0] at week 1). In eyes requiring retreatment, higher baseline VSS was correlated with earlier time of retreatment (Pearson <jats:italic>r</jats:italic> = −0.9997; <jats:italic>P</jats:italic> &amp;amp;lt; .001).</jats:p></jats:sec><jats:sec id="ab-zoi221468-10"><jats:title>Conclusions and Relevance</jats:title><jats:p>In this study, VSS decreased after ranibizumab treatment, consistent with clinical disease regression. In cases of ROP reactivation requiring retreatment, VSS increased again to values comparable with baseline values. In addition, a greater change in VSS during the first week after initial treatment was found to be associated with a higher risk of later ROP reactivation, and high baseline VSS was correlated with earlier retreatment. These findings may have implications for monitoring ROP regression and reactivation after anti-VEGF treatment.</jats:p></jats:sec>
  • Access State: Open Access