First Author: N.Wadhwa INDIA
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Macular oedema (ME) is the most important cause of loss of vision in patients with central retinal vein occlusion (CRVO). Various clinical trials have demonstrated the efficacy of intravitreal anti-VEGF agents for treatment of macular oedema secondary to CRVO. Intravitreal aflibercept injection (IAI) has been recently shown to be efficacious and safe in the treatment of the same. The purpose of this study was to evaluate the safety and efficacy of off-label use of molecule identical to aflibercept, known as Ziv-aflibercept (Zaltrap) as an intravitreal injection, in treatment naïve eyes of patients with ME secondary to CRVO.
Single centre, single surgeon, prospective interventional case series
Patients with macular oedema secondary to CRVO having central macular thickness of > 250 micrometres and best corrected visual acuity < 20/40 were enrolled in the study. After explaining the experimental nature of treatment and obtaining written informed consent, sixteen treatment naïve eyes of 16 patients with proven macular involvement on FFA and SD-OCT due to CRVO were treated with intravitreal Ziv-aflibercept injection (IZI) (1.25 mg/0.05 ml). Treatment response was monitored with BCVA and SD-OCT measurements on monthly basis and patients monitored for any adverse events. Any patient who developed clinically significant ocular neovascularisation was offered pan retinal photocoagulation. Repeat injections were given monthly on pro re nata basis till central subfield thickness reduced below 250 µm and there was resolution of subretinal fluid or intraretinal cystic changes. Rescue IZI was given if central subfield thickness increased by 50 µm. Statistical analysis was done using IBM SPSS v 22 and non-parametric test (Wilcoxon signed rank test) used for analysis.
Out of 16 patients enrolled in the study, 9 patients were males while 7 patients were females, the average age of patients being 52 + 7.8 years. The patients were followed up for a mean period of 6 + 1.7 months. Out of 16 eyes, treatment end point could be achieved in 14 eyes after a mean of 2.7 + 1.1 injections. The central subfield thickness decreased by a mean of 275 + 111.5 um (p<.001) from 531.56 + 101.59µm to 256.5 + 61.06 µm. Mean reduction was significant at 1st month follow-up (p< 0.001) as well as subsequent follow ups when compared to baseline (p<0.001). BCVA increased by a mean of 12.2 + 3.4 letters on ETDRS. None of the patients developed neovascularization of the retina or iris. Rescue injection was given in one eye after central subfield thickness increased by> 50 micrometers during follow up besides an eye developing transient raised IOP which was managed medically. None of the eyes developed any signs of intraocular inflammation or cataract.
In this small interventional case series, we could substantiate that IZI is an effective and safe low cost alternative to IAI in treating ME secondary to CRVO with significant improvements in both anatomic and functional parameters. PRN dosing regimen with monthly evaluation for at least a year is effective to not only prevent disease progression but plays a role in visual and anatomic gains.