Browsing by Author "Yang, Michael B."

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    Low- and Very Low-Dose Bevacizumab for Retinopathy of Prematurity: Reactivations, Additional Treatments, and 12-Month Outcomes
    (Elsevier, 2022) Freedman, Sharon F.; Hercinovic, Amra; Wallace, David K.; Kraker, Raymond T.; Li, Zhuokai; Bhatt, Amit R.; Boente, Charline S.; Crouch, Eric R.; Hubbard, G. Baker; Rogers, David L.; VanderVeen, Deborah; Yang, Michael B.; Cheung, Nathan L.; Cotter, Susan A.; Holmes, Jonathan M.; Pediatric Eye Disease Investigator Group; Ophthalmology, School of Medicine
    Purpose: Low-dose and very low-dose intravitreal bevacizumab (IVB) have been reported to be successful in short-term treatment of type 1 retinopathy of prematurity (ROP), down to an initial dose of 0.004 mg. We now report 12-month outcomes for these infants. Design: Masked, multicenter, dose de-escalation study. Participants: One hundred twenty prematurely born infants with type 1 ROP. Methods: A cohort of 120 infants with type 1 ROP in at least 1 eye from 2 sequential dose de-escalation studies of low-dose IVB (0.25 mg, 0.125 mg, 0.063 mg, and 0.031 mg) or very low-dose IVB (0.016 mg, 0.008 mg, 0.004 mg, and 0.002 mg) to the study eye; the fellow eye (if also type 1) received 1 dose level higher of IVB. After primary success or failure at 4 weeks, clinical management was at investigator discretion, including all additional treatment. Main outcome measures: Reactivation of severe ROP by 6 months corrected age, additional treatments, retinal and other ocular structural outcomes, and refractive error at 12 months corrected age. Results: Sixty-two of 113 study eyes (55%) and 55 of 98 fellow eyes (56%) received additional treatment. Of the study eyes, 31 (27%) received additional ROP treatment, and 31 (27%) received prophylactic laser therapy for persistent avascular retina. No trend toward a higher risk of additional ROP treatment related to initial IVB doses was found. However, time to reactivation among study eyes was shorter in eyes that received very low-dose IVB (mean, 76.4 days) than in those that received low-dose IVB (mean, 85.7 days). At 12 months, poor retinal outcomes and anterior segment abnormalities both were uncommon (3% and 5%, respectively), optic atrophy was noted in 10%, median refraction was mildly myopic (-0.31 diopter), and strabismus was present in 29% of infants. Conclusions: Retinal structural outcomes were very good after low- and very low-dose IVB as initial treatment for type 1 ROP, although many eyes received additional treatment. The rate of reactivation of severe ROP was not associated with dose; however, a post hoc data-driven analysis suggested that reactivation was sooner with very low doses.
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    Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial
    (Springer Nature, 2021) Adams-Chapman, Ira; Watterberg, Kristi L.; Nolen, Tracy L.; Hirsch, Shawn; Cole, Carol A.; Cotten, C. Michael; Oh, William; Poindexter, Brenda B.; Zaterka-Baxter, Kristin M.; Das, Abhik; Backstrom Lacy, Conra; Scorsone, Ann Marie; Duncan, Andrea F.; DeMauro, Sara B.; Goldstein, Ricki F.; Colaizy, Tarah T.; Wilson-Costello, Deanne E.; Purdy, Isabell B.; Hintz, Susan R.; Heyne, Roy J.; Myers, Gary J.; Fuller, Janell; Merhar, Stephanie; Harmon, Heidi M.; Peralta-Carcelen, Myriam; Kilbride, Howard W.; Maitre, Nathalie L.; Vohr, Betty R.; Natarajan, Girija; Mintz-Hittner, Helen; Quinn, Graham E.; Wallace, David K.; Olson, Richard J.; Orge, Faruk H.; Tsui, Irena; Gaynon, Michael; Hutchinson, Amy K.; He, Yu-Guang; Winter, Timothy W.; Yang, Michael B.; Haider, Kathryn M.; Cogen, Martin S.; Hug, Denise; Bremer, Don L.; Donahue, John P.; Lucas, William R.; Phelps, Dale L.; Higgins, Rosemary D.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of Medicine
    Objective: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. Study design: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. Results: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). Conclusions: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.