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Title: Efficacy and safety of an aflibercept treat-and-extend regimen in treatment-naive patients with macular oedema secondary to central retinal vein occlusion (CRVO): a prospective 12-month, single-arm, multicentre trial
Author: García Arumí, José
Gómez Ulla, Francisco
Amparo, Navea
Cervera, Enrique
Fonollosa, Alex
Arias Barquet, Lluís
Araiz, Javier
Donate, Juan
Suárez de Figueroa, Marta
Manzanas, Lucía
Crespi, Jaume
Gallego Pinazo, Roberto
Keywords: Malalties de la retina
Estudi de casos
Retinal diseases
Case studies
Issue Date: 14-Oct-2018
Publisher: Hindawi
Abstract: Objectives: to evaluate efficacy and safety of an aflibercept treat-and-extend (TAE) regimen in patients with macular oedema (MO) secondary to central retinal vein occlusion (CRVO). Design setting and patients: phase IV, prospective, open-label, single-arm trial in 11 Spanish hospitals. Treatment-naïve patients with <6 month diagnosis of MO secondary to CRVO and best-corrected visual acuity (BCVA) of 73-24 ETDRS letters were included between 23 January 2015 and 17 March 2016. Intervention: intravitreal aflibercept 2 mg monthly (3 months) followed by proactive individualized dosing. Main outcomes: mean change in BCVA after 12 months. Results: 24 eyes (24 patients) were included; mean (SD) age: 62.8 (15.0) years; 54.2% male; median (IQR) time since diagnosis: 7.6 (3.0, 15.2) days. Mean BCVA scores significantly improved between baseline (56.0 (16.5)) and Month 12 (74.1 (17.6)); mean (95% CI) change: 14.8 (8.2, 21.4); P=0.0001. Twelve (50.0%) patients gained ≥15 ETDRS letters. Foveal thickness improved between baseline (mean: 569.4 (216.8) µm) and Month 12 (mean 257.4 (48.4) µm); P < 0.0001. At Month 12, 8.3% patients had MO. The mean (SD) number of injections: 8.3 (3.0). No treatment-related AEs were reported. Five (20.8%) patients experienced ocular AEs. Two nonocular serious AEs were reported. Conclusions: an aflibercept TAE regimen improves visual acuity in patients with MO secondary to CRVO over 12 months with good tolerability.
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It is part of: Journal of Ophthalmology, 2018, vol. 2018, p. 8310350
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ISSN: 2090-004X
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)

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