Short-term safety of 2 mg of intravitreal ziv-aflibercept in different retinal pathologies

Abstract

Purpose: To assess the safety and effectiveness of 2 mg ziv-ablifercept (ZA) in different retinal diseases. Methods: Single arm, open-label, prospective study. A 2 mg (0.08 mL) ZA dose was administered following the hospital protocols for topical anesthesia. The following were considered adverse effects: IOP >3 mmHg from baseline, retinal detachment, vitreous hemorrhage, endophthalmitis, retinal vasculitis, retinal necrosis, cataract progression, anterior and posterior uveitis. Results: The study included 91 eyes of 55 patients and 50% were men, with a median age of 64.26 ± 11.86 years, a mean of 1.68 ± 0.91 injections; baseline central foveal thickness (CFT) of 390. 91 ± 162.01 microns compared to a final CFT of 319.02 ± 104.67 microns (p = 0.000). Baseline best corrected visual acuity (BCVA) in logMAR was 0.86 ± 0.49 compared to a final BCVA of 0.75 ± 0.48 (p = 0.000). No adverse effects were reported. Conclusions: ZA is a safe and effective medication for the treatment of macular edema, regardless of the etiology, and it is also an affordable medication. Long-term studies are needed to evaluate its effectiveness compared to those drugs already approved for intravitreal use.

Effectiveness of the Use of Three-Dose Intravitreal Ziv-Aflibercept in the Management of Diabetic Macular Edema in a Real-Life Setting

“…The largest case series published to date where intravitreal Ziv-aflibercept is used as treatment for diverse macular pathologies (5914 patients) reported the following adverse effects: 1 case of endophthalmitis, 3 cases of intraocular inflammation, 1 case of conjunctival thinning and necrosis, and 1 case of scleral nodule, 1 case of central retinal artery obstruction. 2 , 11 , 13 , 16 Adverse events are not much different than any other antiangiogenic drug. Prior studies and our study are indicative that Ziv-aflibercept is a safe medication for short- and long-term ophthalmic use (the largest follow-up study was up to 48 months).…”

“…5 , 8 , 13 , 17 Studies have also been performed using 2 mg/0.08mL and 2.5 mg/0.1mL, and no differences were found regarding safety and effectiveness compared to 1.25 mg/0.05 mL. 9 , 10 , 16 , 18–20 …”