Session Title: Vascular Diseases and Diabetic Retinopathy III
Session Date/Time: Friday 12/09/2014 | 16:30-18:00
Paper Time: 17:18
Venue: Boulevard D
First Author: : S.Nicoara ROMANIA
Co Author(s): : C. Nascutzy C. Cristian I. Irimescu A.C Stefanut G. Zaharie
This study has three objectives: 1. To evaluate the number of premature infants with severe retinopathy of prematurity (ROP), in which we administered Avastin intravitreally, between January 1st 2009 - July 31st 2013. 2. To describe the evolution of ROP in the new born infants from the study sample, translated by: rate of ROP regression, necessity of laser photocoagulation, complication rate, structural outcomes. 3. To identify the factors associated with the outcomes of avastin monotherapy among the new born infants from the study sample.
This is a case-control, non-comparative, consecutive, interventional, retrospective case series that was undertaken at the “Iuliu Hatieganu” University of Medicine and Pharmacy from Cluj-Napoca, Romania. The study was approved by the Ethics Commitee of this institution. The patients were enrolled after having obtained the informed consent from the parents/tutors.
We analized the files of all the consecutive infants whom we treated by intravitreal injections of Avastin for severe ROP, between January 1st 2009 - July 31st 2013. We defined severe ROP as one of the three categories: aggressive posterior, stage 3 zone I and stage IVA. A dose of Avastin of 0.625 mg in 0.025 ml was injected in each eye, at 1.5 - 1.75 mm from the limbus. The patients were re-examined the next day and then every week, to monitor the regression of the disease. The follow-up continued for 6 months, every 1 or 2 weeks until the full vascularization of the retina. Photographs of the retina were taken with a Ret Cam (Clarity Medical System, Pleasanton, California, USA). The following data were recorded: gestational age (GA), birth weight (BW), gender, type of pregnancy (unique, multiple), postmenstrual age (PMA) and postnatal age (PNA) at treatment, fundus findings, complications, follow-up period. We performed statistical analysis with the program SPSS 20.0.0 (Chicago, Illinois, USA). We used chi-square test to calculate the correlations between the categorical variables. In case of unequal data distribution, the p value was given by Fisher’s exact test. The p value <0.05 was considered statistically significant.
Between January 1st 2009 - July 31st 2013, we injected Avastin intravitreally for ROP in 80 eyes belonging to 40 premature infants, 18 males (45%) and 22 females (55%). GA was between 26 and 34 weeks (median 28 weeks ± 1.9 SD), BW was between 800 g and 2300 g (median 1100 g ± 323.31 SD). PNA at treatment varied between 4 and 12 weeks (median 6 weeks ± 1.66 SD) and PMA at treatment, between 31 and 40 weeks (median 35 weeks ± 1.82 SD). Of the 80 eyes, 52 had AP-ROP (65%), 23 - stage III zone 1 (28.75%) and 5 - stage IVA (6.25%). ROP regressed after one Avastin injection in 68 eyes (85%). In 11 of the 12 eyes in which ROP failed to regress after one Avastin injection, laser photocoagulation was performed, with good evolution in all cases. Fischer's test proved that the success rate was significantly higher in zone 1 stage 3 ROP, as compared with AP-ROP (p=0.015). Chi square test proved that the success rate was significantly higher if Avastin injection was performed within 6 weeks after birth (p=0.007). We report no local or systemic complications subsequent to Avastin injections on our series.
The success rate of Avastin monotherapy in severe forms of ROP was 85% on our series. This is a significantly higher success rate in severe ROP, as compared to conventional laser therapy that we previously reported (54.16%). The outcome was significantly better in zone I stage 3 ROP as compared to AP-ROP. The success rate was significantly higher if treatment was performed within the first 6 weeks after birth. The outcome of Avastin monotherapy was not influenced by: gender, type of pregnancy, GA, BW and PMA at treatment. The findings that sustain the intravitreal injection of Avastin as the first choice treatment in severe forms of ROP, according to our study, are: the better outcomes as compared to conventional laser therapy, the simplicity of treatment, the continuation of retinal vascularization, the lack of local and systemic complications. Further studies and longer follow- ups are needed in order to define the role of intravitreal Avastin injections in the management of ROP.