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


Autoři: Imoro Zeba Braimah aff001;  Ernest Kenu aff003;  Kwesi N. Amissah-Arthur aff001;  Stephen Akafo aff001;  Kwaku Oppong Kwarteng aff002;  Winfried M. Amoaku aff004
Působiště autorů: Department of Surgery (Eye), School of Medicine and Dentistry, College of Health Sciences, University of Ghana, Accra, Ghana aff001;  Eye Centre, Korle- Bu Teaching Hospital, Korle- Bu, Accra, Ghana aff002;  Department of Epidemiology, School of Public Health, University of Ghana, Accra, Ghana aff003;  Academic Ophthalmology, DCN, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, England, United Kingdom aff004
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223944

Souhrn

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.

Klíčová slova:

Adverse events – Eye diseases – Eyes – Ghana – Intraocular pressure – Ocular anatomy – Ocular system – Visual acuity


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2019 Číslo 10