First-Year Visual Acuity Outcomes of Providing Aflibercept According to the VIEW Study Protocol for Age-Related Macular Degeneration

• Published in: Ophthalmology (Rochester, Minn.) Vol. 123; no. 2; pp. 337 - 343
• Main Authors: Talks, James S., MRCP, FRCOphth, Lotery, Andrew J., MD, FRCOphth, Ghanchi, Faruque, FRCOphth, Sivaprasad, Sobha, FRCOphth, Johnston, Robert L., FRCOphth, Patel, Nishal, MD, FRCOphth, McKibbin, Martin, FRCOphth, Bailey, Clare, FRCOphth, Mahmood, Sajjad, FRCOphth
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2016
• Subjects: Aged; Aged, 80 and over; Angiogenesis Inhibitors - therapeutic use; Clinical Protocols; Electronic Health Records; Female; Fluorescein Angiography; Humans; Intravitreal Injections; Male; Middle Aged; Ophthalmology; Receptors, Vascular Endothelial Growth Factor - therapeutic use; Recombinant Fusion Proteins - therapeutic use; Retrospective Studies; Tomography, Optical Coherence; Treatment Outcome; United Kingdom; Vascular Endothelial Growth Factor A - antagonists & inhibitors; Visual Acuity - physiology; Wet Macular Degeneration - diagnosis; Wet Macular Degeneration - drug therapy; Wet Macular Degeneration - physiopathology; neovascular age-related macular degeneration; pro re nata; electronic medical record; VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD; nAMD; EMR; PRN; VIEW
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/j.ophtha.2015.09.039

Purpose Aflibercept has the potential advantage of reducing capacity problems by allowing 2 monthly visits for patients with neovascular macular degeneration (nAMD) compared with monthly pro re nata regimens that are the most commonly used in the United Kingdom. This study aimed to report the visual outcomes achieved in routine clinical practice using the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) protocol at 1 year and compare with trials data and other real-world reports. Design Retrospective data analysis from an electronic medical record. Participants Consecutive series of treatment-naïve patients initiated on aflibercept for nAMD at least 1 year before data extraction. Methods Data were anonymized and remotely extracted from 16 centers in the United Kingdom that use the same electronic medical record (EMR) system (Medisoft Ophthalmology; Medisoft Limited, Leeds, UK). Main Outcome Measures The minimum data set defined before first data entry and mandated by the EMR included age, gender, visual acuity, injection episodes, and complications. Results The mean age was 80.0 years (median, 81.0 years) and 63.7% were women. During the first year of treatment with aflibercept, 1840 treatment-naïve eyes of 1682 patients received a median of 8 (mean, 7.0) injections at a median of 8 (mean, 7.3) visits. The mean baseline visual acuity was 53.7 letters, improving to 58.8 letters (+5.1-letter gain) at 1 year. In first-treated eyes, the respective figures were 52.7 letters at baseline and 58.2 letters at 1 year, a gain of +5.5 letters. The proportion achieving 70 letters or more increased from 16.4% at baseline to 33.7% at 1 year, and 92% avoided moderate visual loss at 1 year. Conclusions The visual acuity outcomes are comparable to randomized trials and better than many previous real-world data collections, with a mean +5.1-letter gain at 1 year compared with +8.4 letters in the integrated analysis of the VIEW 1 and VIEW 2 studies. Early visual gains were maintained through the year. Collection of outcomes beyond clinical trials can have limitations but better reflect the full pool of patients actually treated and are important to determine whether a particular treatment is performing as expected. Such data also have the potential to improve services by setting up a mechanism to compare sites.