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In this trial, one intravitreal injection of bevacizumab was administered to treat retinopathy of prematurity of stage 3+. Bevacizumab was more effective than conventional laser therapy in preventing recurrence of neovascularization in infants with zone I but not zone II posterior retinopathy. Retinopathy of prematurity is a neovascular retinal disorder of childhood that causes loss of vision by means of macular dragging and retinal detachment. It is a leading cause of childhood blindness in the United States and other highly industrialized nations, occurring primarily in infants of low birth weight (≤1250 g; mean, 700 g). 1 The incidence of blindness in infants due to retinopathy of prematurity is relatively low, about 1 case in 820 infants, 2 because of good neonatal care and appropriate screening and treatment. 1 The disorder is a major cause of childhood blindness in developing countries, manifesting in larger premature infants . . .

Background Severe retinopathy of prematurity (ROP) is associated with adverse outcomes. Relationships between milder ROP and outcomes have not been defined. We hypothesized that children with ROP stage ≤3 who did not receive ophthalmologic intervention would have worse motor, cognitive, and language skills and more vision abnormalities than children without ROP. Methods This was a secondary analysis of a randomized trial evaluating the effects of myo -inositol on ROP in the NICHD Neonatal Research Network. Primary outcomes were Bayley Scales of Infant Development composite scores; secondary outcomes included behavioral difficulties and ophthalmologic measures. Outcomes were compared using adjusted linear or modified Poisson models. Results Of 506 children, 173 (34%) had no ROP, 262 (52%) had ROP stage ≤3 without intervention, and 71 (14%) had ROP with intervention. There was no difference in motor, cognitive, or language scores between children with ROP stage ≤3 without intervention and children without ROP. Children with ROP stage ≤3 without intervention had a higher rate of strabismus compared to children without ROP ( p  = 0.040). Conclusion Children with ROP stage ≤3 without intervention did not have adverse neurodevelopmental outcomes at 2 years’ corrected age compared to children without ROP but did have an increased incidence of strabismus. Impact This study addresses a gap in the literature regarding the relationship between milder forms of retinopathy of prematurity (ROP) that regress without intervention and neurodevelopment and vision outcomes. Children with a history of ROP stage ≤3 without intervention have similar neurodevelopmental outcomes at 2 years’ corrected age as children born extremely preterm without a history of ROP and better outcomes than children with a history of ROP with ophthalmologic intervention. Counseling about likely neurodevelopment and vision outcomes for children born extremely preterm with a history of ROP may be tailored based on the severity of ROP. Clinical trial registration ClinicalTrials.gov ID: Inositol to Reduce Retinopathy of Prematurity Trial: NCT01954082.

This report of the three BOOST II trials, undertaken to examine optimum oxygen saturation in extremely preterm infants, showed that targeting levels below 90% with the use of current oximeter calibrations was associated with increased mortality. The clinically appropriate range for oxygen saturation in preterm infants is unknown. Trials in the 1950s showed that unrestricted oxygen increased the rate of severe retinopathy of prematurity. However, when oxygen was subsequently restricted, increased mortality was observed. 1 The first Benefits of Oxygen Saturation Targeting (BOOST) trial showed that in preterm infants who were still receiving oxygen at 32 weeks' gestation, targeting a higher oxygen-saturation range prolonged oxygen dependence. 2 Observational studies suggested that higher oxygen-saturation levels may increase rates of retinopathy of prematurity. 3 – 5 In five randomized, masked trials with similar protocols conducted in the United States, 6 Australia, New Zealand, . . .

ObjectiveTo identify achieved oxygen saturations (SpO2) associated with increased risk of severe retinopathy of prematurity (ROP).DesignThis is a secondary analysis of the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT)randomised controlled trial. SpO2 was recorded up to 36 weeks’ postmenstrual age. Saturations through 9 postnatal weeks were explored graphically, and logistic regression models were created to predict severe ROP.Setting20 centres of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network.Patients984 surviving infants of 24–27 weeks’ gestational age born in 2005–2009.InterventionsSUPPORT targeted SpO2 to a lower (85%–89%) or higher (91%–95%) range through 36 weeks’ postmenstrual age or off respiratory support.Main outcome measuresSevere ROP defined as threshold ROP, ophthalmological surgery or bevacizumab treatment.ResultsThere were statistically significant interactions between duration of oxygen supplementation and percentage of time in certain achieved saturation ranges. Specifically, for infants who spent at least 2 weeks on oxygen in postnatal weeks 1–5, a higher percentage of time at 91%–96% SpO2 was associated with increased odds of severe ROP. For infants who spent at least 3 weeks on oxygen in postnatal weeks 6–9, a higher percentage of time at 97%–100% SpO2 was associated with increased odds of severe ROP. Other significant risk factors were lower gestational age and birth weight, non-Hispanic white versus black race, prospectively defined severe illness, late-onset sepsis or meningitis, and clinical centre.ConclusionsAmong extremely preterm survivors to discharge, the association between SpO2 and severe ROP depended on the timing and duration of oxygen supplementation.

This large randomized trial with a 2-by-2 factorial design compared a lower target range of oxygen saturation (85 to 89%) with a higher target range (91 to 95%) in extremely preterm infants. The lower target range did not significantly decrease the combined outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. A lower target range of oxygen saturation did not significantly decrease the combined outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. Retinopathy of prematurity is an important cause of blindness and other visual disabilities in preterm infants. The incidence of retinopathy of prematurity was increased with exposure to unrestricted oxygen supplementation in preterm infants in randomized, controlled trials performed in the 1950s. 1 In the 1960s, this increase resulted in the practice of restricting the fraction of inspired oxygen (FIO 2 ) to no more than 0.50, which was estimated to result in an excess of 16 deaths per case of blindness prevented. 2 More recent data suggest that levels of oxygen saturation previously thought to be at the upper end of the . . .

Purpose: The aim of this study was to report the treatment outcomes of early and deferred laser in infants of aggressive posterior retinopathy of prematurity (APROP) after initial treatment with intravitreal Ranibizumab (IVR). Methods: In a prospective, randomized, interventional study, infants with APROP received IVR (0.25 mg) and were randomized into two groups prior to laser. Laser was done at 1 week (group 1) or at 6 weeks or earlier if there was a recurrence of plus disease (group 2). The structural outcome, number of laser spots, duration of laser procedure and refractive error at 6 months were compared. Favorable structural outcome was defined as, complete regression of disease at 6 weeks after laser. Results: 63 eyes of 32 infants with APROP were enrolled. Mean gestational age (GA) and birth weight (BW) were 30.2 ± 2.3 weeks and 1294 ± 372.8 grams respectively. GA, BW, and disease severity were comparable at baseline. 27 (90%) eyes in group 1 and 29 (93.5%) eyes in group 2 had favorable structural outcome (P = 0.61) at 6 weeks after laser. Eyes in group 2 (2149.8 ± 688.7) required lesser number of laser spots than group 1 (2570.8 ± 615) (P = 0.01). At six months, more eyes in group 1 had myopic refractive error (Mean spherical equivalent: -1.0D ± 1.3) than those in group 2 (Mean spherical equivalent: 0.5D ± 1.9) (P = 0.002). Conclusion: Infants with APROP receiving IVR have comparable structural outcomes after an early or deferred laser. Moreover, eyes undergoing deferred laser require less number of laser spots and have a less myopia at 6 months after laser.

PurposeTo investigate whether the observed international differences in retinopathy of prematurity (ROP) treatment rates within the Benefits of Oxygen Saturation Targeting (BOOST) II trials might have been caused by international variation in ROP disease grading.MethodsGroups of BOOST II trial ophthalmologists in UK, Australia, and New Zealand (ANZ), and an international reference group (INT) used a web based system to grade a selection of RetCam images of ROP acquired during the BOOST II UK trial. Rates of decisions to treat, plus disease grading, ROP stage grading, ROP zone grading, inter-observer variation within groups and intra-observer variation within groups were measured.ResultsForty-two eye examinations were graded. UK ophthalmologists diagnosed treat-requiring ROP more frequently than ANZ ophthalmologists, 13.9 (3.49) compared to 9.4 (4.46) eye examinations, P=0.038. UK ophthalmologists diagnosed plus disease more frequently than ANZ ophthalmologists, 14.1 (6.23) compared to 8.5 (3.24) eye examinations, P=0.021. ANZ ophthalmologists diagnosed stage 2 ROP more frequently than UK ophthalmologists, 20.2 (5.8) compared to 12.7 (7.1) eye examinations, P=0.026. There were no other significant differences in the grading of ROP stage or zone. Inter-observer variation was higher within the UK group than within the ANZ group. Intra-observer variation was low in both groups.ConclusionsWe have found evidence of international variation in the diagnosis of treatment-requiring ROP. Improved standardisation of the diagnosis of treatment-requiring ROP is required. Measures might include improved training in the grading of ROP, using an international approach, and further development of ROP image analysis software.

This article reviews retinopathy of prematurity, particularly regarding oxygen use, and describes current and potential therapies based on mechanistic studies in models relevant to current oxygen stresses in preterm infants. Retinopathy of prematurity is a vision-threatening disease associated with abnormal retinal vascular development that occurs only in premature infants. 1 Low birth weight and prematurity are strongly associated with an increased risk of the disease. 2 In the Early Treatment for Retinopathy of Prematurity study, the disorder developed in 68% of premature infants born in the United States and weighing less than 1251 g; among infants with the disorder, severe retinopathy of prematurity developed in almost 37%. 1 The incidence of premature births is increasing throughout the world, and with it, retinopathy of prematurity is now appearing in countries with the technology to . . .

PurposeTo evaluate the visual field after anti-vascular endothelial growth factor (VEGF) therapy and laser treatment for retinopathy of prematurity.MethodRetrospective cohort study. Infants with retinopathy of prematurity treated by anti-VEGF therapy or laser treatment were included in the study. Degrees of visual field in eight directions examined by Goldmann perimeter (intensity, 1000 apostilb; size, V4e = 64 mm2) were compared between the anti-VEGF therapy and laser treatment groups. The visual acuity (VA) and spherical equivalent refraction were also compared between the two groups.ResultsNine eyes with anti-VEGF therapy and 12 eyes with laser treatment were enrolled in the analysis. The total, upper, nasal upper, nasal, nasal lower, temporal lower, and temporal upper visual fields were significantly wider in the eyes with anti-VEGF therapy than in those with laser treatment (496 vs 416, P = .002; 53 vs 45, P = .008; 56 vs 43, P = .003; 58 vs 39, P < .001; 55 vs 44, P = .01; 72 vs 65, P = .01; and 62 vs 56, P = .03, respectively). The logarithm of the minimum angle of resolution VA tended to be better in the eyes with anti-VEGF therapy than in those with laser treatment (0.01 vs 0.15, P = .06). Eyes with anti-VEGF therapy had significantly lower myopia than those with laser treatment (spherical equivalent refraction: -0.72 vs -5.7, P = .001).ConclusionAnti-VEGF therapy may provide a wider visual field, better VA, and less myopia compared with laser treatment.

Despite increasing worldwide use of anti-vascular endothelial growth factor agents for treatment of retinopathy of prematurity (ROP), there are few data on their ocular efficacy, the appropriate drug and dose, the need for retreatment, and the possibility of long-term systemic effects. We evaluated the efficacy and safety of intravitreal ranibizumab compared with laser therapy in treatment of ROP. This randomised, open-label, superiority multicentre, three-arm, parallel group trial was done in 87 neonatal and ophthalmic centres in 26 countries. We screened infants with birthweight less than 1500 g who met criteria for treatment for retinopathy, and randomised patients equally (1:1:1) to receive a single bilateral intravitreal dose of ranibizumab 0·2 mg or ranibizumab 0·1 mg, or laser therapy. Individuals were stratified by disease zone and geographical region using computer interactive response technology. The primary outcome was survival with no active retinopathy, no unfavourable structural outcomes, or need for a different treatment modality at or before 24 weeks (two-sided α=0·05 for superiority of ranibizumab 0·2 mg against laser therapy). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02375971. Between Dec 31, 2015, and June 29, 2017, 225 participants (ranibizumab 0·2 mg n=74, ranibizumab 0·1 mg n=77, laser therapy n=74) were randomly assigned. Seven were withdrawn before treatment (n=1, n=1, n=5, respectively) and 17 did not complete follow-up to 24 weeks, including four deaths in each group. 214 infants were assessed for the primary outcome (n=70, n=76, n=68, respectively). Treatment success occurred in 56 (80%) of 70 infants receiving ranibizumab 0·2 mg compared with 57 (75%) of 76 infants receiving ranibizumab 0·1 mg and 45 (66%) of 68 infants after laser therapy. Using a hierarchical testing strategy, compared with laser therapy the odds ratio (OR) of treatment success following ranibizumab 0·2 mg was 2·19 (95% Cl 0·99–4·82, p=0·051), and following ranibizumab 0·1 mg was 1·57 (95% Cl 0·76–3·26); for ranibizumab 0·2 mg compared with 0·1 mg the OR was 1·35 (95% Cl 0·61–2·98). One infant had an unfavourable structural outcome following ranibizumab 0·2 mg, compared with five following ranibizumab 0·1 mg and seven after laser therapy. Death, serious and non-serious systemic adverse events, and ocular adverse events were evenly distributed between the three groups. In the treatment of ROP, ranibizumab 0·2 mg might be superior to laser therapy, with fewer unfavourable ocular outcomes than laser therapy and with an acceptable 24-week safety profile. Novartis.