Abstract
Purpose:
To describe the outcomes of patients with exudative age-related macular degeneration (AMD) that received intravitreal injections of ziv-aflibercept.
Methods:
This study was designed to evaluate the retinal safety of intravitreal ziv-aflibercept. Patients with exudative AMD refractory to bevacizumab and treatment-naive patients were included. After approval by the Ethics Committee of the Federal University of São Paulo (IRB number 707.034), Brazil, and signature of the informed consent form, all patients were examined through a complete ophthalmological exam, ETDRS best-corrected visual acuity (BCVA), color fundus image, fluorescein angiogram (FA), optical coherence tomography (OCT), microperimetry and multifocal and full-field electroretinography (ERG). An intravitreal injection of ziv-aflibercept (0.1 mL, 25 mg/mL, total 2.5 mg), under sterile conditions, was performed. After three monthly injections (induction), patients were examined monthly, and subsequent injections were performed as needed (pro re nata). Patients with choroidal neovascularization in both eyes were excluded. Visual acuity, OCT and microperimetry were performed monthly, color fundus image and FA every 6 months, and full-field and multifocal ERG at baseline, 1 and 3 months. Each patient was required to return every 4 weeks for evaluation.
Results:
Our research group performed intravitreal injections of ziv-aflibercept in patients with recalcitrant fluid despite many bevacizumab injections, and in treatment-naive patients. At presentation, all patients demonstrated subretinal fluid or cystic spaces in OCT, associated or not with proteinaceous exudates with fibrin deposition. A response was noticed after the initial injection in all patients and a somewhat greater response was seen after the following injections. All patients experienced improvement in the BCVA and in the microperimetric fixation targets, when baseline and follow-up was compared. Mean rod and maximal responses were higher when compared to baseline. No adverse events were reported.
Conclusions:
This case series showed that intravitreal ziv-aflibercept was safe to our patients' retinas and could be a cost-effective option for patients which AMD. However, more patients are needed to confirm the retinal safety and efficacy of intravitreal ziv-aflibercept.