Safety of intravitreal ziv-aflibercept in choroido-retinal vascular diseases: A randomised double-blind intervention study

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.

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

“…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 …”

“…In addition, Baghi et al found a reduction in central macular thickness (313±120 μm) also very similar to results found in our study using Ziv-aflibercept (324 ± 114 μm). 18 …”

Efficacy of intravitreal ziv-aflibercept in patients with macular edema following retinal vein occlusion in Korle-Bu Teaching Hospital, Ghana: a retrospective case series

“…Disease activity recurrence was defined as a macula that is dry (absence of IRF and SRF) followed by the observation of fluid at subsequent visits, BCVA loss of at least one line on the VA chart with evidence of fluid in the macula or increase in CSFT of at least 100 lm on OCT. IVZ IVZ was administered as per institutional protocol. Details of the protocol for the preparation of IVZ prior to intravitreal injection have been reported previously [19]. The intravitreal injection is done using a sterile technique.…”

“…IVZ was administered as per institutional protocol. Details of the protocol for the preparation of IVZ prior to intravitreal injection have been reported previously [ 19 ]. The intravitreal injection is done using a sterile technique.…”

“…There are few reports on the safety and efficacy of off-label intravitreal ziv-aflibercept (IVZ) in patients with ME secondary RVO [14][15][16][17][18][19][20]. However, no reports exist on the efficacy of IVZ in African patients with macular edema secondary to RVO.…”