@article{74b7be04a57d4abb9be1907cf8613b13,
title = "Low- and Very Low-Dose Bevacizumab for Retinopathy of Prematurity: Reactivations, Additional Treatments, and 12-Month Outcomes",
abstract = "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.",
keywords = "Bevacizumab, Pediatric ophthalmology, Retinopathy of prematurity",
author = "{Pediatric Eye Disease Investigator Group} and Freedman, {Sharon F.} and Amra Hercinovic and Wallace, {David K.} and Kraker, {Raymond T.} and Zhuokai Li and Bhatt, {Amit R.} and Boente, {Charline S.} and Crouch, {Eric R.} and Hubbard, {G. Baker} and Rogers, {David L.} and Deborah VanderVeen and Yang, {Michael B.} and Cheung, {Nathan L.} and Cotter, {Susan A.} and Holmes, {Jonathan M.} and Prakalapakorn, {Sasapin G.} and Jones, {Sarah K.} and Barman, {Navajyoti R.} and House, {Robert J.} and Nasrazadani, {David A.} and Eric Crouch and Crouch, {Earl R.} and Ventura, {Gaylord G.} and Dosunmu, {Eniolami O.} and Gray, {Michael E.} and Motley, {William W.} and Katherine Castleberry and Patricia Cobb and Patricia Hirsch and Melissa Reed and Sandoval, {Monica A.} and Neil Vallabh and Bremer, {Don L.} and Golden, {Richard P.} and Jordan, {Catherine O.} and McGregor, {Mary Lou} and Reem, {Rachel E.} and Schreckengost, {Amanda N.} and Maletic, {Sara A.} and Miller, {Rachel T.} and Coats, {David K.} and Gihan Romany and Demmy, {Ann B.} and Kong, {Lingkun X.} and Hartnett, {Mary E.} and Dries, {David C.} and Hoffman, {Robert O.} and Susan Allman and Farnsworth, {Katie J.} and Barbara Hart and Kelliann Ordonez and Hutchinson, {Amy K.} and Hubbard, {George B.} and Prethy Rao and Robinson, {Joshua E.} and Brower, {Judy L.} and Haider, {Kathryn M.} and Smith, {Heather A.} and Hynes, {Elizabeth A.} and Whitaker, {Michele E.} and VanderVeen, {Deborah K.} and Mantagos, {Jason S.} and Carolyn Wu and Samantha Goldstein and Tamar Winter and Yoon, {Grace X.} and Siatkowski, {R. Michael} and Collinge, {Janine E.} and Satnes, {Kelli J.} and Blunt, {Michelle H.} and Repka, {Michael X.} and Courtney Kraus and Shepard, {Jennifer A.} and Beck, {Roy W.} and Austin, {Darrell S.} and Boyle, {Nicole M.} and Chandler, {Danielle L.} and Connelly, {Patricia L.} and Conner, {Courtney L.} and Quayleen Donahue and Fimbel, {Brooke P.} and Henderson, {Robert J.} and Hoepner, {James E.} and Kaplon, {Joseph D.} and Melia, {B. Michele} and Gillaine Ortiz and Robinson, {Julianne L.} and Stutz, {Kathleen M.} and Sutherland, {Desirae R.} and Toro, {David O.} and Woodard, {Victoria C.} and Rui Wu and Birch, {Eileen E.} and Chen, {Angela M.} and Christiansen, {Stephen P.} and Enyedi, {Laura B.} and Erzurum, {S. Ayse} and Everett, {Donald F.} and Good, {William V.} and Jenewein, {Erin C.} and Lee, {Katherine A.} and Richard London and Manh, {Vivian M.} and Manny, {Ruth E.} and Morrell, {Beth A.} and Morrison, {David G.} and Petersen, {David B.} and Pineles, {Stacy L.} and Ranaivo, {Hantamalala Ralay} and Roberts, {Tawna L.} and Ruark, {Scott T.} and Schweinler, {Bonita R.} and Silver, {Jayne L.} and Suh, {Donny W.} and Summers, {Allison I.} and Verderber, {Lisa C.} and Weise, {Katherine K.} and Marie Diener-West and Baker, {John D.} and Barry Davis and Phelps, {Dale L.} and Poff, {Stephen W.} and Saunders, {Richard A.} and Lawrence Tychsen",
note = "Publisher Copyright: {\textcopyright} 2022 American Academy of Ophthalmology",
year = "2022",
month = oct,
doi = "10.1016/j.ophtha.2022.05.019",
language = "English",
volume = "129",
pages = "1120--1128",
journal = "Ophthalmology",
issn = "0161-6420",
number = "10",
}