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Refractive outcomes following bevacizumab monotherapy compared with conventional laser treatment: a randomized
Megan M Geloneck1, Alice Z Chuang1, W Lloyd Clark2
1Ruiz Department of Ophthalmology and Visual Science, The University of Texas Health Science Center-Houston Medical School, Houston.
Insights
Intravitreal bevacizumab treatment for retinopathy of prematurity (ROP) resulted in less very high myopia compared to laser therapy. This finding suggests potential benefits for anterior segment development in ROP management.
Area of Science:
- Ophthalmology
- Neonatal Medicine
- Pediatric Medicine
Background:
- Retinopathy of prematurity (ROP) is a significant cause of vision impairment in premature infants.
- ROP, particularly aggressive posterior ROP (APROP), can lead to severe visual complications, including high myopia.
- Laser therapy has been a standard treatment, but concerns remain regarding long-term refractive outcomes.
Purpose of the Study:
- To compare refractive outcomes in preterm infants with ROP treated with intravitreal bevacizumab versus laser therapy.
- To evaluate the incidence of very high myopia in different ROP zones based on treatment modality.
Main Methods:
- A prospective, randomized, controlled, multicenter trial (BEAT-ROP) involving preterm infants with ROP.
- Infants received either intravitreal bevacizumab or laser therapy, with treatment randomized.
- Cycloplegic retinoscopic refraction was performed at a mean age of 2.5 years to assess refractive outcomes.
Main Results:
- Eyes treated with laser therapy showed significantly higher rates of very high myopia (≥-8.00 D) in both zone I (51.4%) and zone II posterior (36.4%) compared to eyes treated with intravitreal bevacizumab (3.8% and 1.7%, respectively).
- Mean spherical equivalent refractions were significantly more myopic in the laser treatment groups across both ROP zones.
- Refractions were available for 83.2% of eligible infants and 82.7% of eligible eyes.
Conclusions:
- Intravitreal bevacizumab treatment for ROP is associated with a lower incidence of very high myopia compared to laser therapy.
- The observed difference may be attributed to the preservation of anterior segment development with intravitreal bevacizumab, which is minimally affected by laser treatment.
Importance:
Children 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.
Objective:
To 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 Participants:
All 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).
Interventions:
Follow-up of the BEAT-ROP cohort.
Main Outcomes And Measures:
Spherical equivalent refractive outcomes and their distribution by ROP zone and treatment.
Results:
Refractions 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 Relevance:
More 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 Registration:
clinicaltrials.gov Identifier: NCT00622726.
