Safety of intravitreal ziv-aflibercept in choroido-retinal vascular diseases: A randomised double-blind intervention study.
Choroid Plexus
/ pathology
Double-Blind Method
Female
Humans
Intravitreal Injections
Macular Edema
/ drug therapy
Male
Middle Aged
Prognosis
Prospective Studies
Receptors, Vascular Endothelial Growth Factor
/ therapeutic use
Recombinant Fusion Proteins
/ therapeutic use
Retinal Diseases
/ drug therapy
Vascular Diseases
/ drug therapy
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2019
2019
Historique:
received:
06
11
2018
accepted:
29
09
2019
entrez:
25
10
2019
pubmed:
28
10
2019
medline:
20
3
2020
Statut:
epublish
Résumé
To evaluate the safety of 1.25mg and 2mg intravitreal ziv-aflibercept (IVZ) in Ghanaian eyes with choroido-retinal vascular diseases. Prospective, randomised, double blind, interventional study. 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. 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). 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.
Identifiants
pubmed: 31647843
doi: 10.1371/journal.pone.0223944
pii: PONE-D-18-31787
pmc: PMC6812750
doi:
Substances chimiques
Recombinant Fusion Proteins
0
aflibercept
15C2VL427D
Receptors, Vascular Endothelial Growth Factor
EC 2.7.10.1
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0223944Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
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