PURPOSE: To compare the efficacy of intravitreal injection of ranibizumab (IVR) monotherapy and laser therapy for treatment-requiring retinopathy of prematurity (ROP) in Zone II.
METHODS: A prospective, randomized, controlled single-center trial was applied from January 2014 to December 2014; infants who were diagnosed as Zone II treatment-requiring ROP (i.e., Zone II Stage 2 or 3 ROP with plus disease) were randomly assigned to receive IVR monotherapy or laser therapy, and the follow-up interval was at least 6 months. Any eyes that developed recurrence of ROP underwent crossover re-treatment.
RESULTS: A total of 100 eyes of 50 ethnic Han Chinese infants were enrolled. At the last follow-up, 26 eyes of 13 infants developed recurrence of ROP in the IVR group and 2 eyes of 1 infant developed recurrence of ROP in the laser therapy group. There was a significant statistical difference in the rate of ROP recurrence between IVR and laser therapy to treat Zone II treatment-requiring ROP (P = 0.001).
CONCLUSION: Although IVR appears to regress ROP to certain levels and continue to promote the vascularization of peripheral retinal vessels, a substantial proportion of infants developed recurrence of ROP after a single-dose IVR. Therefore, IVR is not recommended as a single-dose monotherapy for Zone II treatment-requiring ROP.
PURPOSE: To assess the effect of intravitreal bevacizumab for Type 1 retinopathy of prematurity (ROP) in zone II ROP.
METHODS: We conducted a randomized clinical trial. Preterm infants with a gestational age less than 34 weeks or birthweight less than 2000 g were examined at 4 weeks chronological age or 31 weeks postmenstrual age (whichever was later). Preterm infants with Zone-II/Stage 2 or 3 and plus disease were included. Eligible infants were randomized to receive either conventional indirect laser therapy or intravitreal bevacizumab injections (0.625 mg/0.025 ml). The primary outcome was defined as treatment failure: ROP persistence or recurrence by 90 weeks postmenstrual age.
RESULTS: Our study population comprised 79 infants (158 eyes) with Zone-II ROP. Randomly, 43 infants (86 eyes) were assigned to receive intravitreal bevacizumab and 36 infants (72 eyes) to receive conventional indirect laser therapy. All the infants were followed up at least until 90 weeks postmenstrual age. Stage-3 ROP recurred in nine eyes (10.5%) in the bevacizumab group and one eye (1.4%) in the laser group (p value = 0.018). In recurrent cases after the second treatment, ROP in eight of the nine eyes (88.8%) in the bevacizumab group and the eye in the laser group regressed.
CONCLUSION: Recurrence of neovascularization with bevacizumab monotherapy seems to be higher than that with conventional laser therapy among infants with Type 1 ROP in zone II ROP but reinjection of bevacizumab causes regression in most recurrent cases.
We conducted a prospective randomized study to compare outcomes of intravitreal Bevacizumab versus diode laser in thirty eyes of fifteen premature babies with zone 1 or posterior zone 2 retinopathy of prematurity (ROP). We recorded complications, regression/reactivation of ROP, visual outcome, refractive error and systemic complications. The Bevacizumab treated eyes showed rapid regression of the ROP with resolution of plus disease and flattening of the ridge at 48 hours post injection. In 3 Bevacizumab treated eyes, reactivation occurred and were treated with laser (3 eyes) or a further Bevacizumab injection (1 eye). Of the diode laser treated eyes, one showed progression and was treated with Bevacizumab. At 5 year follow up, good outcomes were observed in both treatment groups. Hoever, less myopia was found in the Bevacizumab compared with the diode laser treated eyes.
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.
PURPOSE: To compare the structural outcome at 9 months of eyes treated with intravitreal injection of bevacizumab with fellow eyes treated with conventional laser photoablation in zone I type 1 retinopathy of prematurity (ROP).
DESIGN: Single randomized controlled trial.
PARTICIPANTS: All inborn babies with type 1 zone I ROP at a single institution were included in the study. One eye was randomized to receive an intravitreal injection of 0.5 mg bevacizumab; the fellow eye received conventional laser photoablation.
METHODS: Digital fundus photographs and fluorescein angiography (FA) using the RetCam (Clarity Medical Systems Inc., Pleasanton, CA) were performed before treatment and 9 months after treatment.
MAIN OUTCOME MEASURES: Presence of retinal and choroidal abnormalities on FA at 9 months.
RESULTS: Thirteen infants were enrolled; 1 died 3 months after birth. One laser-treated eye progressed to stage 5 retinal detachment. The remaining 23 eyes had favorable structural results at the 9-month follow-up and provided FA results. At 9 months of age, all eyes treated with a bevacizumab injection were noted to have abnormalities at the periphery (large avascular area, abnormal branching, shunt) or the posterior pole (hyperfluorescent lesion, absence of foveal avascular zone). These posterior and peripheral lesions were not observed in the majority of the lasered eyes.
CONCLUSIONS: This study documents significant vascular and macular abnormalities of eyes in the bevacizumab group. Long-lasting implications of these abnormalities for visual function of the child need to be studied.
PURPOSE: To investigate efficacy of intravitreal injection of pegaptanib and laser photocoagulation for treatment of stage 3+ retinopathy of prematurity (ROP) affecting zone I and posterior zone II, and to compare the results in terms of regression, development of peripheral retinal vessels, and final structural outcome with conventional laser photocoagulation or combined with cryotherapy.
METHODS: In a prospective comparative study, 152 eyes with zone I, II posterior ROP 3+ (76 premature rabies), from 2009 to 2011, were included. Patients were randomly assigned to receive intravitreal pegaptanib (Macugen® 0.3 mg = 0.02 mL, Pfizer) with conventional diode laser photocoagulation in group 1 (68 eyes of 34 infants) or only laser therapy combined with cryotherapy in group 2 (84 eyes of 42 infants), bilaterally. The primary outcome of treatment success was defined as absence of recurrence of stage 3+ ROP. The mean follow-up after treatment was 19.3 months in group 1 and 21.5 months in group 2.
RESULTS: Final favorable anatomic outcome and stable regression of ROP at last control examination was noted in 89.7% of eyes in group 1 and 60.8 % of eyes in group 2. Regression of plus disease and peripheral retinal vessels development appeared significantly more rapidly in group 1. No recurrence of neovascularization (stage 3+ ROP) was identified in 85.4% of patients in group 1 and 50% of patients in group 2.
CONCLUSIONS: Results of this study support the administration of intravitreal pegaptanib as useful therapy in the management of stage 3+ ROP.
BACKGROUND: Retinopathy of prematurity is a leading cause of childhood blindness worldwide. Peripheral retinal ablation with conventional (confluent) laser therapy is destructive, causes complications, and does not prevent all vision loss, especially in cases of retinopathy of prematurity affecting zone I of the eye. Case series in which patients were treated with vascular endothelial growth factor inhibitors suggest that these agents may be useful in treating retinopathy of prematurity. METHODS: We conducted a prospective, controlled, randomized, stratified, multicenter trial to assess intravitreal bevacizumab monotherapy for zone I or zone II posterior stage 3+ (i.e., stage 3 with plus disease) retinopathy of prematurity. Infants were randomly assigned to receive intravitreal bevacizumab (0.625 mg in 0.025 ml of solution) or conventional laser therapy, bilaterally. The primary ocular outcome was recurrence of retinopathy of prematurity in one or both eyes requiring retreatment before 54 weeks' postmenstrual age. RESULTS: We enrolled 150 infants (total sample of 300 eyes); 143 infants survived to 54 weeks' postmenstrual age, and the 7 infants who died were not included in the primary-outcome analyses. Retinopathy of prematurity recurred in 4 infants in the bevacizumab group (6 of 140 eyes [4%]) and 19 infants in the laser-therapy group (32 of 146 eyes [22%], P = 0.002). A significant treatment effect was found for zone I retinopathy of prematurity (P = 0.003) but not for zone II disease (P = 0.27). CONCLUSIONS: Intravitreal bevacizumab monotherapy, as compared with conventional laser therapy, in infants with stage 3+ retinopathy of prematurity showed a significant benefit for zone I but not zone II disease. Development of peripheral retinal vessels continued after treatment with intravitreal bevacizumab, but conventional laser therapy led to permanent destruction of the peripheral retina. This trial was too small to assess safety. (PsycInfo Database Record (c) 2021 APA, all rights reserved)
The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.
To compare the efficacy of intravitreal injection of ranibizumab (IVR) monotherapy and laser therapy for treatment-requiring retinopathy of prematurity (ROP) in Zone II.
METHODS:
A prospective, randomized, controlled single-center trial was applied from January 2014 to December 2014; infants who were diagnosed as Zone II treatment-requiring ROP (i.e., Zone II Stage 2 or 3 ROP with plus disease) were randomly assigned to receive IVR monotherapy or laser therapy, and the follow-up interval was at least 6 months. Any eyes that developed recurrence of ROP underwent crossover re-treatment.
RESULTS:
A total of 100 eyes of 50 ethnic Han Chinese infants were enrolled. At the last follow-up, 26 eyes of 13 infants developed recurrence of ROP in the IVR group and 2 eyes of 1 infant developed recurrence of ROP in the laser therapy group. There was a significant statistical difference in the rate of ROP recurrence between IVR and laser therapy to treat Zone II treatment-requiring ROP (P = 0.001).
CONCLUSION:
Although IVR appears to regress ROP to certain levels and continue to promote the vascularization of peripheral retinal vessels, a substantial proportion of infants developed recurrence of ROP after a single-dose IVR. Therefore, IVR is not recommended as a single-dose monotherapy for Zone II treatment-requiring ROP.
