title: Determinants of visual acuity outcomes in eyes with neovascular AMD treated with anti-VEGF agents: an instrumental variable analysis of the AURA study.
abstract: PurposeTo identify the strongest variable(s) linked with the number of ranibizumab injections and outcomes in AURA, and to identify ways to improve outcomes using this association.MethodsAURA was a large observational study that monitored visual acuity over a 2-year period in patients with neovascular age-related macular degeneration (AMD) who received ranibizumab injections. Baseline characteristics, resource use, and outcomes were analyzed using an instrumental variable approach and regression analysis.ResultsData were analyzed from 2227 patients enrolled in AURA. Optical coherence tomography (OCT) and ophthalmoscopy were the most common diagnostic tests used, and this combination was the strongest instrumental variable. Use of OCT and ophthalmoscopy affected the number of injections given and resulted in an increase in visual acuity gains from baseline of 17.6 letters in year 1 and 2.5 letters in year 2. Regression models using the instrumental variable (OCT and ophthalmoscopy combined) showed that ≥5.1 (95% CI: 3.3-11.4) ranibizumab injections were needed to maintain visual acuity from baseline to year 1 and ≥8.3 (95% CI: 5.3-18.8) injections were needed to maintain visual acuity from year 1 to year 2. To gain ≥15 letters, ≥7.9 (95% CI: 5.1-17.5) ranibizumab injections would be needed in year 1 and ≥16.1 (95% CI: 10.3-36.4) injections would be needed over 2 years.ConclusionsThese findings highlight the role that regular monitoring plays in guiding neovascular AMD therapy and they showed that the number of ranibizumab injections needed to maintain visual acuity is higher than that administered in AURA.
authors.affiliation: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors.forename: F G
authors.initials: FG
authors.lastname: Holz
authors.affiliation: Department of Ophthalmology, Hôpital Lariboisière, Paris, France.
authors.forename: R
authors.initials: R
authors.lastname: Tadayoni
authors.affiliation: Department of Ophthalmology, Institute of Eye Surgery, Waterford, Ireland.
authors.forename: S
authors.initials: S
authors.lastname: Beatty
authors.affiliation: Department of Ophthalmology and Vision Sciences, University of Toronto, and St Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: A R
authors.initials: AR
authors.lastname: Berger
authors.affiliation: Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.
authors.forename: M G
authors.initials: MG
authors.lastname: Cereda
authors.affiliation: NIHR Biomedical Centre for Research in Ophthalmology, Moorfields Eye Hospital, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Hykin
authors.affiliation: Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Staurenghi
authors.affiliation: Bayer Pharmaceuticals, Berlin, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Wittrup-Jensen
authors.affiliation: Mapi Group, Real World Strategy and Analysis, Stockholm, Sweden.
authors.forename: J
authors.initials: J
authors.lastname: Nilsson
authors.affiliation: Health Economics, AstraZeneca Nordic-Baltic, Södertälje, Sweden.
authors.forename: K
authors.initials: K
authors.lastname: Kim
authors.affiliation: NIHR Biomedical Centre for Research in Ophthalmology, Moorfields Eye Hospital, London, UK.|Department of Ophthalmology, King's College Hospital, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Sivaprasad
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D058449:Intravitreal Injections; D009887:Ophthalmoscopy; D000069579:Ranibizumab / Q000008:administration & dosage / Q000627:therapeutic use; D012189:Retrospective Studies; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology; D057135:Wet Macular Degeneration / Q000188:drug therapy / Q000503:physiopathology
chemical_list: D020533:Angiogenesis Inhibitors; D000069579:Ranibizumab; D042461:Vascular Endothelial Growth Factor A; C467484:VEGFA protein, human