Safety of intravitreal ziv-aflibercept in choroido-retinal vascular diseases: A randomised double-blind intervention study
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Date
2019-10-24
Journal Title
Journal ISSN
Volume Title
Publisher
Plos One
Abstract
Aim
To evaluate the safety of 1.25mg and 2mg intravitreal ziv-aflibercept (IVZ) in Ghanaian eyes
with choroido-retinal vascular diseases.
Design
Prospective, randomised, double blind, interventional study.
Methods
Twenty 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.
Results
Eleven 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).
Conclusion
IVZ 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.
Description
Research Article
Keywords
intravitreal ziv-aflibercept (IVZ), choroido-retinal vascular diseases, double blind, macular oedema
Citation
Braimah IZ, Kenu E, Amissah-Arthur KN, Akafo S, Kwarteng KO, AmoakuWM(2019) Safety of intravitreal ziv-aflibercept in choroido-retinal vascular diseases: A randomised double-blind intervention study. PLoS ONE 14(10): e0223944. https://doi.org/10.1371/journal.pone.0223944