Elsevier

Ophthalmology

Volume 121, Issue 5, May 2014, Pages 1092-1101
Ophthalmology

Original article
The Neovascular Age-Related Macular Degeneration Database: Multicenter Study of 92 976 Ranibizumab Injections: Report 1: Visual Acuity

https://doi.org/10.1016/j.ophtha.2013.11.031Get rights and content
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open access

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.

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Supplemental material is available at www.aaojournal.org.

Financial Disclosure(s): The author(s) have made the following disclosure(s):

Robert L. Johnston: Employee – Medisoft Limited.

Supported in part by an unrestricted grant from Novartis Pharmaceuticals UK Limited, Frimley, UK. No member or affiliate of Novartis had any input into data analysis, interpretation of the data, or writing the manuscript. This research received a proportion of its funding from the Department of Health's NIHR Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital and UCL Institute of Ophthalmology. The views expressed in the publication are those of the authors and not necessarily those of the Department of Health.

Correspondence: Adnan Tufail, MD, FRCOphth, Moorfields Eye Hospital NHS Trust, 162 City Road, London EC1V 2PD, United Kingdom. E-mail: [email protected].

A complete list of members of the UK Age-Related Macular Degeneration EMR Users Group is available at www.aaojournal.org.Writing Committee for the UK Age-Related Macular Degeneration EMR Users Group: Adnan Tufail, MD, FRCOphth; Wen Xing, MSc; Robert Johnston, FRCOphth; Toks Akerele, MD, FRCOphth; Martin McKibbin, FRCOphth; Louise Downey, MBChB, FRCOphth; Salim Natha, MBChB, FRCOphth; Usha Chakravarthy, MD, PhD; Clare Bailey, MD, FRCOphth; Rehna Khan, MB, ChB; Richard Antcliff, FRCOphth; Stewart Armstrong, FRCOphth; Atul Varma, MSCOphth; Vineeth Kumar, FRCSEd(Ophth); Marie Tsaloumas, MBBS, FRCOphth; Kaveri Mandal, FRCSEd(Ophth); and Catey Bunce, DSc.