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 evaluate the efficacies and treatment outcomes following intravitreal bevacizumab (IVB), intravitreal ranibizumab (IVR), and laser photocoagulation (LPC) in retinopathy of prematurity (ROP).
METHODS: This was a retrospective interventional case series study including the data of 134 infants (264 eyes) who were treated with IVB, IVR, or LPC for ROP. The data were collected from two major ROP treatment centers in Turkey without any randomization or masking. Regression of ROP, recurrence profile, complications after each treatment modality, and indications for retreatment were evaluated. The main outcome measures included the total inactivation of ROP with anatomic and refractive outcomes at 1.5 years of adjusted age.
RESULTS: There were 55 infants (41.1%) in the IVB group, 22 infants (16.4%) in the IVR group, and 57 infants (42.5%) in the LPC group. All but 3 infants (5.5%) in the IVB group and 11 infants (50%) in the IVR group showed recurrence to stage 1 and 2 ROP following IVB and IVR (p < 0.001). Retreatment was performed in three infants in both IVB and IVR groups (p = 0.098). At 1.5 years of adjusted age, all infants showed favorable anatomic outcome except one infant in the LPC group. No significant difference of the mean spherical equivalent (SE) was observed between the groups (p = 0.131). In Zone I ROP, laser treated infants had significantly higher rates of myopia and high myopia than IVB and IVR treated infants (p = 0.040 and p = 0.019, respectively).
CONCLUSIONS: Both IVB and IVR treated infants had significantly better refractive outcomes in Zone I ROP as compared to LPC treated infants at 1.5 years of adjusted age. The higher rate of disease recurrence was associated with IVR. Gestational age (GA) and the zone of ROP were also predictive factors for recurrence of ROP in the study.
PURPOSE: The German retinopathy of prematurity (ROP) Registry collects data on treated ROP in a multicentre approach to analyse epidemiology and treatment patterns of severe ROP.
METHODS: Nine centres entered data from 90 treated ROP infants (born between January 2011 and December 2013) into a central database. Analysis included incidence rate of severe ROP, demographic data, stage of ROP, treatment patterns, recurrence rates, relevant comorbidities and ophthalmological or systemic complications associated with treatment.
RESULTS: Treatment rate for ROP was 3.2% of the screened population. The most frequent ROP stage at time of treatment was zone II, stage 3 + (137 eyes). Treatment was bilateral in 97% of infants. Treatment patterns changed over time from 7% anti-vascular endothelial growth factor (VEGF) monotherapy in 2011 to 32% in 2014. Overall, laser treatment was the predominant treatment. However, all infants with zone I disease received anti-VEGF treatment. About 19% of infants required retreatment (16% of laser-treated and 21% of anti-VEGF treated infants). Mean time between first and second treatment was 3.8 weeks (± 11 days) for laser-treated and 10.4 weeks (± 60 days) for anti-VEGF-treated infants.
CONCLUSION: This study is the first multicentre analysis of severe ROP in Germany. The identified treatment patterns find laser as the most prevalent form of therapy, with an increasing use of anti-VEGF therapy over recent years. Recurrence rates were relatively high overall with slightly higher recurrence rates and later recurrence times in the anti-VEGF group. Anti-VEGF was predominantly used for high-risk stages like AP-ROP and zone I disease.
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.
PURPOSE: To demonstrate the clinical characteristics and treatment outcomes of severe retinopathy of prematurity (ROP) in preterm infants with birth weight (BW) above 1500 g in Turkey.
METHODS: A retrospective review of 5920 ROP records was performed in Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital. The records were obtained from ROP treatment center of the same institute between 2011 and 2016. The data comprised the demographic and clinical characteristics including, gestational age, BW, systemic risk factors, zone and stage of ROP, ROP type, treatment modality, treatment outcomes and inborn/outborn status of the babies.
RESULTS: A total of 36 infants (71 eyes) with severe ROP and BW> 1500 g were retrieved. There were 30 infants (83.3%) with type 1 ROP and 6 infants (16.7%) with aggressive posterior ROP (APROP). 3 infants (8.3%) were born at our hospital whereas 33 (91.7%) were referred from outer private neonatal intensive care unit (NICU) centers. Zone I APROP was detected during the initial screening. 21 infants (58.3%) underwent laser treatment while 15 (41.7%) received intravitreal bevacizumab (IVB) injections. No unfavorable structural outcome was observed following either treatment modality.
CONCLUSION: Severe ROP may occur in heavier preterm infants. Laser treatment and IVB injections were useful in selected cases. Presence of APROP at first examination suggests an earlier screening in heavier babies. Standardization of private NICU centers as well as establishing a national ROP protocol is necessary in Turkey.
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.
PURPOSE: To compare the effect and the treatment outcomes of bevacizumab and ranibizumab in the treatment of Type 1 retinopathy of prematurity (ROP).
METHODS: This was a bicentered retrospective case series performed at institutional referral centers. Seventy-two eyes of 37 patients who had intravitreal injections of either bevacizumab or ranibizumab as the primary treatment for Type 1 ROP were included. Outcomes' measures included regression and recurrence of ROP, the surgical complications, and refractive errors at a corrected age of 1 year.
RESULTS: All but one eye in the bevacizumab group had retinal neovascularization and plus disease regression after anti-vascular endothelium growth factor treatment. Neither recurrence of ROP nor major ocular complications, including cataract, retinal detachment, and endophthalmitis occurred in any of the treated eyes. There were no significant differences in mean refractive errors between the patients treated with intravitreal injections of bevacizumab or ranibizumab at the corrected age of 1 year. A significantly higher chance of high myopia was noted in the bevacizumab group (P = 0.03).
CONCLUSION: Both bevacizumab and ranibizumab showed similar efficacy in the regression of ROP with minor mean refractive errors at 1 year of corrected age. However, high myopia was more prevalent in the bevacizumab-treated eyes.
PURPOSE: To evaluate the refractive development of premature infants with retinopathy of prematurity (ROP) after treatment with laser photocoagulation or intravitreal injection of bevacizumab (IVB).
METHODS: The medical records of patients with ROP treated between 2003 and 2012 who underwent yearly follow-ups were retrospectively reviewed. Patients with residual ROP abnormalities were excluded. The cycloplegic refraction at 3 years of age, assessed using an autorefractometer, was recorded.
RESULTS: In total, 54 eyes from 54 patients were enrolled. Patients were divided into 4 groups: group 1, including 14 eyes of 14 patients treated with laser therapy; group 2, 15 eyes of 15 patients treated with IVB; group 3, 13 eyes of 13 patients with non-type 1 ROP under conservative follow-up, and group 4, 12 eyes of 12 premature patients without ROP. The mean spherical equivalent at 3 years of age was -1.71 ± 1.27 dpt in group 1, -1.53 ± 2.20 dpt in group 2, 0.63 ± 1.37 dpt in group 3, and 0.41 ± 1.95 dpt in group 4. The mean refractive error differed significantly among the 4 groups (p < 0.001). Patients in groups 1 and 2 were more prone to myopia compared with those in groups 3 and 4. Furthermore, patients with type 1 ROP treated by laser photocoagulation (group 1) and those treated by IVB (group 2) had similar refraction (p = 1).
CONCLUSIONS: The results of this study suggest that treatment-demanding ROP eyes are susceptible to more severe myopia with age compared with eyes without ROP or those with spontaneously regressed ROP. In addition, the myopic status between laser and IVB treatment did not differ statistically.
PURPOSE: To study the efficacy of intravitreal bevacizumab (IVB) injection as a single treatment for retinopathy of prematurity (ROP).
METHODS: This was a prospective interventional case series study performed in a clinical practice setting; a total of 122 patients including prethreshold (type 1) (n = 79, 152 eyes, six unilateral), threshold (n = 12, 24 eyes), and aggressive posterior (APROP) (n = 31, 62 eyes); cases were included without any randomization or masking. A total of 253 IVB injections, 238 in the first session, 11 in the second session, and four in the third session were performed, and followed up for a mean of 89.155 ± 4.277 (range 82 to 105) weeks of postmenstrual age (PMA). Regression of ROP, maturation of the retina, and associated complications were evaluated.
RESULTS: Total regression was achieved in 227/238 eyes (95.4 %) after the first dose injection. The remaining 11 received a second injection, after which an additional seven (234/238; 98.2 %) regressed; after the third injection, the remaining 4 (238/238; 100 %) regressed. Complete retinal vascular maturation was achieved without any significant complications in all of the cases.
CONCLUSIONS: IVB injection as monotherapy seems to be a very effective treatment modality for ROP. Based on timely intervention, IVB as a single treatment modality can salvage almost all ROP cases before stage 4.
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.
