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http://hdl.handle.net/2445/175618
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DC Field | Value | Language |
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dc.contributor.author | Garweg, Justus G. | - |
dc.contributor.author | Stefanickova, Jana | - |
dc.contributor.author | Hoyng, Carel | - |
dc.contributor.author | Schmelter, Thomas | - |
dc.contributor.author | Niesen, Tobias | - |
dc.contributor.author | Sowade, Olaf | - |
dc.contributor.author | Sivaprasad, Sobha | - |
dc.contributor.author | AQUA Investigators | - |
dc.contributor.author | Arias Barquet, Lluís | - |
dc.date.accessioned | 2021-03-23T10:54:28Z | - |
dc.date.available | 2021-03-23T10:54:28Z | - |
dc.date.issued | 2019-07-01 | - |
dc.identifier.issn | 2468-6530 | - |
dc.identifier.uri | http://hdl.handle.net/2445/175618 | - |
dc.description.abstract | Purpose: To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY). Design: AQUA was a multicenter, open-label, single-arm, phase 4 study. Participants: Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME. Methods: Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks. Main outcome measures: The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated. Results: A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was -175.38 μm (SD, 132.62 μm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related. Conclusions: Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept. | eng |
dc.format.extent | 9 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Elsevier B.V. | - |
dc.relation.isformatof | Versió postprint del document publicat a: https://doi.org/10.1016/j.oret.2019.03.012 | - |
dc.relation.ispartof | Ophthalmology Retina , 2019, vol. 3, num. 7, p. 567-575 | - |
dc.relation.uri | https://doi.org/10.1016/j.oret.2019.03.012 | - |
dc.rights | cc-by-nc-nd (c) American Academy of Ophthalmology, 2019 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Angiogènesi | - |
dc.subject.classification | Retinopatia diabètica | - |
dc.subject.classification | Factor de creixement de l'endoteli vascular | - |
dc.subject.other | Neovascularization | - |
dc.subject.other | Diabetic retinopathy | - |
dc.subject.other | Vascular endothelial growth factors | - |
dc.title | Vision-related quality of life in patients with diabetic macular edema treated with intravitreal aflibercept: The AQUA Study | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/acceptedVersion | - |
dc.identifier.idgrec | 706653 | - |
dc.date.updated | 2021-03-23T10:54:28Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) |
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