Or iginal s tud y IVZ in neovascular AMD
Autumn 2021 • Vol 16 | No 2 SA Ophthalmology Journal
25
Efficacy and safety of ziv-aflibercept in patients with neovascular age-related macular degeneration in a Ghanaian population IZ Braimah MBChB, FGCS, FWACS; Senior lecturer and consultant ophthalmologist, Department of Surgery (Eye), University of Ghana Medical School, Korle-Bu, Accra; Lions International Eye Centre, Korle-Bu Teaching Hospital, Korle-Bu, Accra, Ghana ORCID ID: https://orcid.org/0000-0002-2573-9026 YS Adam MBBS; Consultant ophthalmologist, Lions International Eye Centre, Korle-Bu Teaching Hospital, Korle-Bu, Accra, Ghana WM Amoaku MBChB, FRCS(Ed), FRCOphth, PhD; Associate Professor/Reader, Academic Ophthalmology, DCN, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK ORCID ID: https://orcid.org/0000-0001-5028-7984 Corresponding author: Winfried M Amoaku, tel: +441158231014; email: winfried.amoaku@nottingham.ac.uk
Abstract Background: To report on the efficacy and safety of intravitreal ziv-aflibercept (IVZ) in a Ghanaian population with neovascular age-related macular degeneration (nAMD). Methods: In this retrospective, observational study, the medical records of patients with nAMD who had been treated with IVZ, 1.25 mg/0.05 ml, as part of routine clinical practice on pro re nata basis with a minimum follow-up of 6 months, were retrieved and analysed. Results: Twenty-four eyes of 23 patients were included in this study. Their mean age was 67.7±8.8 yrs, and mean duration of follow-up was 11.4±4.0 months. Nine (37.5%) eyes were presumed to have polypoidal choroidal vasculopathy (PCV). The mean baseline best-corrected visual acuity (BCVA) was 1.1±0.7 logMAR; there was significant improvement in BCVA at 3 and 6 months compared to baseline (p<0.01). Seventy-nine per cent of eyes had visual gain of at least one logMAR BCVA line at 6 months post-initiation of IVZ. The mean CMT at baseline was 332.4±138.8 μm; there was significant reduction in CMT at
Introduction
Suppor ts
3, 6 and 12 months compared to baseline (p<0.01). One case of culture-proven endophthalmitis was successfully treated with pars plana vitrectomy and intravitreal antimicrobials. Conclusion: IVZ at 1.25 mg was associated with significant improvement in visual and anatomic outcomes in Ghanaian eyes with nAMD. There was one serious adverse event with unfavourable visual outcome. Keywords: ziv-aflibercept, endophthalmitis, Ghana, neovascular macular degeneration, optical coherence tomography Funding: This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Conflict of interest: The authors have no conflicts of interest to declare.
Vascular endothelial growth factor (VEGF) plays an important role in the pathogenesis of nAMD.4 While ranibizumab (Lucentis, Genentech/Novartis) and aflibercept (Eylea, Regeneron /Bayer) have been approved by the United State of America (USA) Food and Drugs Agency (FDA) and European Medicines Agency (EMA) for intravitreal use in patients with nAMD, bevacizumab (Avastin, Genentech/Roche) and ziv-aflibercept (Regeneron/Sanofi) have been approved by both agencies for the treatment of colorectal cancers. 5,6 The Comparison of Age-Related Macular Degeneration Treatment Trials (CATT) and Inhibition of VEGF in Age-related
Choroidal Neovascularisation (IVAN)
have reported that ranibizumab all 3 layers of the tear film | Preservative free trials and bevacizumab have similar efficacy in
Age-related macular degeneration (AMD) is a major cause of visual impairment and blindness worldwide.1 There are significant differences in the prevalence of different types of AMD including neovascular AMD (nAMD) between different ethnic groups. 2 The prevalence of early AMD is higher among people of European ancestry compared to African and Asian ancestry. 2 Late AMD is more prevalent among people of European ancestry compared to African ancestry. 2 Polypoidal choroidal vasculopathy (PCV), a variant of nAMD, has been found to be more prevalent among Asians and African Americans compared to Caucasians. 3
patients with nAMD.7,8 The VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) 1 and 2 studies have shown that aflibercept has similar efficacy as ranibizumab in nAMD.9,10 Bevacizumab is widely used off-label for the treatment of nAMD due to its cost-effectiveness compared to ranibizumab.11 Aflibercept is expensive and beyond the reach of many patients in developing and low- to middle-income countries in the world. Zivaflibercept (an intravenous formulation of aflibercept) has been used off-label for the treatment of nAMD and there are
