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
Joint Authors
Suarez-De-Figueroa, Marta
Araiz, Javier
García-Arumí, José
Cervera, Enrique
Manzanas, Lucía
Fonollosa, Alex
Donate, Juan
Crespí, Jaume
Gallego, Roberto
Gómez-Ulla, Francisco
Navea-Tejerina, Amparo
Arias, L.
Source
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-10-14
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
García-Arumí, José& Gómez-Ulla, Francisco& Navea-Tejerina, Amparo& Cervera, Enrique& Fonollosa, Alex& Arias, L.…[et al.]. 2018. 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. Journal of Ophthalmology،Vol. 2018, no. 2018, pp.1-7.
https://search.emarefa.net/detail/BIM-1196973
Modern Language Association (MLA)
García-Arumí, José…[et al.]. 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. Journal of Ophthalmology No. 2018 (2018), pp.1-7.
https://search.emarefa.net/detail/BIM-1196973
American Medical Association (AMA)
García-Arumí, José& Gómez-Ulla, Francisco& Navea-Tejerina, Amparo& Cervera, Enrique& Fonollosa, Alex& Arias, L.…[et al.]. 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. Journal of Ophthalmology. 2018. Vol. 2018, no. 2018, pp.1-7.
https://search.emarefa.net/detail/BIM-1196973
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1196973