Abstract
AimTo evaluate the safety of 1.25mg and 2mg intravitreal ziv-aflibercept (IVZ) in Ghanaian eyes with choroido-retinal vascular diseases.DesignProspective, randomised, double blind, interventional study.MethodsTwenty patients with centre involving macular oedema in diabetic retinopathy, retinal vein occlusion, and neovascular age-related macular degeneration were assigned to 2 groups receiving 3 doses of 1.25mg/0.05ml (group 1) and 2mg/0.08ml IVZ (Group 2) at 4 weekly intervals. Safety data was collected after 30 minutes, 1 and 7 days, and 4, 8 and 12 weeks after injection. Changes in continuous variables were compared using paired t-test and categorical variables were compared using chi-square test of proportions. Repeated-Measures ANOVA with nesting test was used to compare variations in continuous variables by IVZ dose over time. Primary outcome measures were ocular and systemic adverse events at 4 weeks.ResultsEleven females and nine males, with mean age of 63.2± 7.3 years were included. Ocular adverse events included subconjunctival haemorrhage in 1 eye, intraocular pressure (IOP) >21mmHg at 30 minutes in 6 eyes and mild pain in 3 eyes at 1-day. There was no significant difference in IOP rise between the 2 groups at 30 minutes (p = 0.21). No other ocular or systemic adverse events were observed. There was significant improvement in the best corrected visual acuity (LogMAR) from 0.95±0.6 to 0.6±0.4 (p<0.01) and 0.47±0.3 (p<0.01), reduction in central subfield foveal thickness from 405.9±140 um at baseline to 255.6±75 um (p<0.01) and 238±88 um (p<0.01) at 4 and 12 weeks respectively, although no difference was observed between the 2 groups (p = 0.34).ConclusionIVZ at 1.25mg and 2mg had similar safety profiles, and did not have any major unexpected adverse events. Further studies with larger cohorts are required to confirm efficacy.
Highlights
Retinal and choroidal vascular diseases such as diabetic macular oedema (DMO), neovascular age-related macular, and macular oedema (MO) following retinal vein occlusions (RVO) are a significant cause of visual impairment in developed countries
There was no significant difference in intraocular pressure (IOP) rise between the 2 groups at 30 minutes (p = 0.21)
Ranibizumab and aflibercept are expensive (US $1950 and $1850 per dose respectively) and many needy patients in developing countries including Ghana lack the funds to pay for these treatments which are self-funded
Summary
Retinal and choroidal vascular diseases such as diabetic macular oedema (DMO), neovascular age-related macular (nvAMD), and macular oedema (MO) following retinal vein occlusions (RVO) are a significant cause of visual impairment in developed countries. They are increasingly becoming important causes of blindness in developing and low-middle income countries including Ghana [1,2,3]. Ranibizumab (Lucentis; Genentech, San Francisco, California, USA/ Novartis, Basel, Switzerland) and aflibercept (Eylea; Regeneron, Tarrytown, New York, USA) have been approved by the USA Food and Drugs Agency (FDA) and European Medicines Agency (EMA) for the treatment of DMO, nvAMD and MO following RVO. The unavailability of rebranded equivalents for poorer countries has compounded the problems in sub-Saharan Africa
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