Purpose: To study real-world ranibizumab therapy for treatment-naïve eyes with neovascular age-related macular degeneration (nAMD) and to benchmark standards of care.
Design: Multicenter, national nAMD database study.
Participants: A total of 92 976 treatment episodes from 12 951 eyes of 11 135 patients.
Methods: Up to 5 years of routinely collected, anonymized data were extracted remotely from 14 United Kingdom centers to a central database using an electronic medical record (EMR) system. Participating centers used ranibizumab to treat nAMD using a loading phase of 3 monthly injections and a pro re nata retreatment regimen. The minimum data set defined before first patient data entry and mandated by the EMR system included age, Early Treatment Diabetic Retinopathy Study visual acuity (VA) at all visits, and injection episodes.
Main outcome measures: Baseline VA, change in VA, number of treatments and clinic visits, and baseline characteristics affecting VA change.
Results: Information from more than 300 000 clinic visits (2.8 million data points) were collated. Mean age at first treatment was 79.1 years, with a female preponderance of 1.7:1. Mean VA (letters) for eyes followed up for at least 3 years from a baseline of 55 letters was 57 (+2) letters at 1 year, 56 (+1) letters at 2 years, and 53 (-2) letters at 3 years. The proportion of eyes that avoided moderate vision loss at years 1, 2, and 3 were 90%, 84%, and 82%, respectively. The proportion of eyes with VA of 20/40 or better were: baseline, 16%; year 1, 30%; year 2, 30%; and year 3, 29%. The median number of treatments for eyes followed up for at least 3 years in years 1, 2 and 3 was 5, 4, and 4, respectively, and the median number of outpatient visits was 9.2, 8.2, and 8.2, respectively. Baseline VA was related inversely to mean vision gain at 3 months. Older age was associated with lower presenting VA.
Conclusions: Real-world visual outcomes achieved at a large number of centers across the United Kingdom do not match the results achieved in most randomized trials, but they were delivered with substantially fewer injections and hospital visits. This study provides important benchmark results that should be of interest to patients, retina specialists, and commissioners of health care. This study demonstrates the EMR system's potential usefulness for future phase 4 and 5 clinical trials.
Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.