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
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-...
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| Format: | Article |
| Language: | English |
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Wiley
2018-01-01
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| Series: | Journal of Ophthalmology |
| Online Access: | http://dx.doi.org/10.1155/2018/8310350 |
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| author | Jose Garcia-Arumi Francisco Gómez-Ulla Navea Amparo Enrique Cervera Alex Fonollosa Luis Arias Javier Araiz Juan Donate Marta Suárez de Figueroa Lucia Manzanas Jaume Crespí Roberto Gallego |
| author_facet | Jose Garcia-Arumi Francisco Gómez-Ulla Navea Amparo Enrique Cervera Alex Fonollosa Luis Arias Javier Araiz Juan Donate Marta Suárez de Figueroa Lucia Manzanas Jaume Crespí Roberto Gallego |
| author_sort | Jose Garcia-Arumi |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a79db6f1aa7444019dfbbc56611e32f4 |
| institution | Kabale University |
| issn | 2090-004X 2090-0058 |
| language | English |
| publishDate | 2018-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Ophthalmology |
| spelling | doaj-art-a79db6f1aa7444019dfbbc56611e32f42025-02-03T01:10:02ZengWileyJournal of Ophthalmology2090-004X2090-00582018-01-01201810.1155/2018/83103508310350Efficacy 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 TrialJose Garcia-Arumi0Francisco Gómez-Ulla1Navea Amparo2Enrique Cervera3Alex Fonollosa4Luis Arias5Javier Araiz6Juan Donate7Marta Suárez de Figueroa8Lucia Manzanas9Jaume Crespí10Roberto Gallego11Hospital Universitari Vall d’Hebron, Barcelona, SpainInstituto Oftalmológico Gómez-Ulla, Complejo Hospitalario Universitario de Santiago de Compostela, A Coruña, SpainFISABIO-Oftalmología Médica, Valencia, SpainHospital General de Valencia, Valencia, SpainHospital Universitario de Cruces, Barakaldo, SpainHospital Universitari de Bellvitge, Barcelona, SpainInstituto Clínico Quirúrgico de Oftalmología, Bilbo, Bizkaia, SpainHospital Clínico San Carlos, Madrid, SpainVISSUM, Madrid, SpainHospital Clínico Universitario de Valladolid, Valladolid, SpainHospital de la Santa Creu i Sant Pau, Barcelona, SpainUnidad de Mácula, Clínica OFTALVIST, Valencia, SpainObjectives. 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.http://dx.doi.org/10.1155/2018/8310350 |
| spellingShingle | Jose Garcia-Arumi Francisco Gómez-Ulla Navea Amparo Enrique Cervera Alex Fonollosa Luis Arias Javier Araiz Juan Donate Marta Suárez de Figueroa Lucia Manzanas Jaume Crespí Roberto Gallego 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://dx.doi.org/10.1155/2018/8310350 |
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