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Refractive Outcomes Following Bevacizumab Monotherapy Compared With Conventional Laser Treatment

Refractive Outcomes Following Bevacizumab Monotherapy Compared With Conventional Laser Treatment ImportanceChildren born prematurely who develop retinopathy of prematurity (ROP) often develop myopia, and those who require laser treatment may develop very high myopia, which has considerable clinical consequences. ObjectiveTo report refractive outcomes in preterm infants who developed ROP in zone I or zone II posterior as stage 3+ ROP or aggressive posterior ROP (APROP). Design, Setting, and ParticipantsAll infants received intravitreal bevacizumab or laser therapy in a prospective, stratified, randomized, controlled, masked, multicenter clinical trial, Bevacizumab Eliminates the Angiogenic Threat for ROP (BEAT-ROP). Children who received intravitreal bevacizumab or laser in the BEAT-ROP clinical trial, with treatment randomized by infant, underwent cycloplegic retinoscopic refraction at a mean age of 2½ years. Fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level 3 neonatal intensive care units in academic centers with institutional review board approval were included in the trial. Of the originally enrolled 150 infants (300 eyes) in the BEAT-ROP clinical trial, 13 infants (26 eyes) died (6 received intravitreal bevacizumab; 7 received laser) and 19 eyes had intraocular surgery (6 infants bilaterally). Thus, 45 eyes (19 infants bilaterally) were excluded, leaving 131 infants (255 eyes, including 21 eyes that received a successful second treatment for recurrence). InterventionsFollow-up of the BEAT-ROP cohort. Main Outcomes and MeasuresSpherical equivalent refractive outcomes and their distribution by ROP zone and treatment. ResultsRefractions were available for 109 of 131 eligible infants (83.2%) and 211 of 255 eyes (82.7%). Mean (SD) spherical equivalent refractions were as follows: zone I, −1.51 (3.42) diopters (D) in 52 eyes that received intravitreal bevacizumab and −8.44 (7.57) D in 35 eyes that received laser treatment (P < .001); and zone II posterior, −0.58 (2.53) D in 58 eyes that received intravitreal bevacizumab and −5.83 (5.87) D in 66 eyes that received laser treatment (P < .001). Very high myopia (≥−8.00 D) occurred in zone I in 2 of 52 (3.8%) eyes that received intravitreal bevacizumab and in 18 of 35 (51.4%) eyes that received laser treatment (P < .001). Very high myopia occurred in zone II posterior in 1 of 58 (1.7%) eyes that received intravitreal bevacizumab and in 24 of 66 (36.4%) eyes that received laser treatment (P < .001). Conclusions and RelevanceMore very high myopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab. This difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment. Trial Registrationclinicaltrials.gov Identifier: NCT00622726 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Ophthalmology American Medical Association

Refractive Outcomes Following Bevacizumab Monotherapy Compared With Conventional Laser Treatment

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Publisher
American Medical Association
Copyright
Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6165
eISSN
2168-6173
DOI
10.1001/jamaophthalmol.2014.2772
pmid
25103848
Publisher site
See Article on Publisher Site

Abstract

ImportanceChildren born prematurely who develop retinopathy of prematurity (ROP) often develop myopia, and those who require laser treatment may develop very high myopia, which has considerable clinical consequences. ObjectiveTo report refractive outcomes in preterm infants who developed ROP in zone I or zone II posterior as stage 3+ ROP or aggressive posterior ROP (APROP). Design, Setting, and ParticipantsAll infants received intravitreal bevacizumab or laser therapy in a prospective, stratified, randomized, controlled, masked, multicenter clinical trial, Bevacizumab Eliminates the Angiogenic Threat for ROP (BEAT-ROP). Children who received intravitreal bevacizumab or laser in the BEAT-ROP clinical trial, with treatment randomized by infant, underwent cycloplegic retinoscopic refraction at a mean age of 2½ years. Fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level 3 neonatal intensive care units in academic centers with institutional review board approval were included in the trial. Of the originally enrolled 150 infants (300 eyes) in the BEAT-ROP clinical trial, 13 infants (26 eyes) died (6 received intravitreal bevacizumab; 7 received laser) and 19 eyes had intraocular surgery (6 infants bilaterally). Thus, 45 eyes (19 infants bilaterally) were excluded, leaving 131 infants (255 eyes, including 21 eyes that received a successful second treatment for recurrence). InterventionsFollow-up of the BEAT-ROP cohort. Main Outcomes and MeasuresSpherical equivalent refractive outcomes and their distribution by ROP zone and treatment. ResultsRefractions were available for 109 of 131 eligible infants (83.2%) and 211 of 255 eyes (82.7%). Mean (SD) spherical equivalent refractions were as follows: zone I, −1.51 (3.42) diopters (D) in 52 eyes that received intravitreal bevacizumab and −8.44 (7.57) D in 35 eyes that received laser treatment (P < .001); and zone II posterior, −0.58 (2.53) D in 58 eyes that received intravitreal bevacizumab and −5.83 (5.87) D in 66 eyes that received laser treatment (P < .001). Very high myopia (≥−8.00 D) occurred in zone I in 2 of 52 (3.8%) eyes that received intravitreal bevacizumab and in 18 of 35 (51.4%) eyes that received laser treatment (P < .001). Very high myopia occurred in zone II posterior in 1 of 58 (1.7%) eyes that received intravitreal bevacizumab and in 24 of 66 (36.4%) eyes that received laser treatment (P < .001). Conclusions and RelevanceMore very high myopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab. This difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment. Trial Registrationclinicaltrials.gov Identifier: NCT00622726

Journal

JAMA Ophthalmology – American Medical Association

Published: Nov 1, 2014

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