Efficacy and safety of an aflibercept treat-and-extend regimen in treatment-naïve patients with macular oedema secondary to Central Retinal Vein Occlusion (CRVO) : A Prospective 12-Month, Single-Arm, Multicentre Trial
García Arumí, José (Hospital Universitari Vall d'Hebron)
Gómez-Ulla, Francisco (Instituto Oftalmológico Gómez-Ulla)
Amparo, Navea (Fundación para la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO))
Cervera, Enrique (Hospital General Universitario de Valencia)
Fonollosa, Alex (Hospital Universitario de Cruces (Barakaldo, País Basc))
Arias Barquet, Lluís (Hospital Universitari de Bellvitge)
Araiz, Javier (Instituto Clinico Quirúrgico de Oftalmologia)
Donate, Juan (Hospital Clínico San Carlos (Madrid))
De Figueroa, Marta Suárez (VISSUM)
Manzanas, Lucia (Hospital Clínico Universitario de Valladolid)
Crespí, Jaume (Institut d'Investigació Biomèdica Sant Pau)
Gallego, Roberto (Clinica OFTALVIST)
Universitat Autònoma de Barcelona

Date:	2018
Abstract:	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. Intravitreal aflibercept 2 mg monthly (3 months) followed by proactive individualized dosing. Mean change in BCVA after 12 months. 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 treatmentrelated AEs were reported. Five (20. 8%) patients experienced ocular AEs. Two nonocular serious AEs were reported. An aflibercept TAE regimen improves visual acuity in patients with MO secondary to CRVO over 12 months with good tolerability.
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Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	Journal of Ophthalmology, Vol. 2018 (2018) , p. 8310350, ISSN 2090-0058

DOI: 10.1155/2018/8310350
PMID: 30405907

7 p, 1.1 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
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