Elsevier

Ophthalmology

Volume 121, Issue 10, October 2014, Pages 1966-1975
Ophthalmology

Original article
The Neovascular Age-Related Macular Degeneration Database: Report 2: Incidence, Management, and Visual Outcomes of Second Treated Eyes

https://doi.org/10.1016/j.ophtha.2014.04.026Get rights and content

Purpose

To study the characteristics of second treated eyes in patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab in the United Kingdom National Health Service.

Design

Multicenter national nAMD database study.

Participants

Twelve thousand nine hundred fifty-one treatment-naïve eyes of 11 135 patients receiving 92 976 ranibizumab injections.

Methods

Up to 5 years of routinely collected, anonymized data within electronic medical record systems were extracted remotely from 14 centers. Participating centers exclusively used ranibizumab to treat nAMD (loading phase of 3 monthly injections followed by monthly visits and pro re nata re-treatment). The minimum data set included: age, logarithm of the minimum angle of resolution (logMAR) visual acuity (VA) at baseline and at all subsequent visits, and injection episodes.

Main Outcome Measures

Baseline, change and actual VA over 3 years, and number of treatments and clinic visits.

Results

During the study, 1816 (16.3%) of the 11 135 patients received treatment to the fellow eye. Mean baseline and final VA were 0.66 (standard deviation, 0.32) and 0.65 (0.40) for first treated eyes and 0.41 (0.34) and 0.56 (0.40) for second treated eyes. The rate of VA loss after the loading phase was similar in first and second treated eyes (0.03 and 0.05 logMAR units/year). When fellow eyes with baseline VA worse than 20/200 were excluded to restrict analyses to eyes at risk of nAMD, the rate of second-eye involvement was 14.0% per year (42%/3 years). Mean number of injections/visits in years 1, 2, and 3 were similar for first and second treated eyes (5.6/8.2, 3.9/8.0, 3.8/8.2 and 5.5/8.7, 3.6/9.4, and 3.8/9.1, respectively).

Conclusions

Second treated eyes with nAMD commence treatment with better baseline VA, do not show significant vision gain but maintain better VA than first treated eyes at all time points for at least 3 years, making them the more important eye functionally. These data highlight the high burden of second eye involvement, with almost half of all eyes at risk requiring bilateral treatment by 3 years, and the need for regular monitoring of fellow eyes for best visual outcomes which theoretically may reduce the benefits of extended monitoring regimens.

Section snippets

Study Design

Two EMR systems from different companies in the UK were known to collect nAMD treatment and assessment data. Sites known to make comprehensive use of these systems were contacted; however, only sites using 1 EMR system met the deadline given with regard to permissions to extract data. All data therefore were derived from 1 supplier (Medisoft Ophthalmology, Medisoft Limited, Leeds, UK). The lead clinician and Caldicott Guardian (who oversees data protection) at each center gave written approval

Participants

The 14 sites entered their first treatment episodes into the EMR system during the following years: 2006 (n = 2 sites), 2007 (n = 5), 2008 (n = 4), 2009 (n = 2), and 2010 (n = 1). The first recorded ranibizumab injection was dated November 2006.

Over the period of data collection, anti-VEGF treatment was performed in 13 774 patients, of whom 2639 received anti-VEGF for reasons other than nAMD or received bevacizumab (Fig 1). Thus, this study analyzes data on 12 951 eyes of 11 135 patients who

Discussion

This is the largest study thus far reported in the literature to focus on the incidence, baseline characteristics, and visual outcomes of second treated eyes that received ranibizumab for nAMD in patients being followed up after treatment of the first eye. The study provides real-world data that highlight several important findings: (1) differences in the characteristics of second treated eyes, including better mean baseline VA than first treated eyes, with maintenance of this difference at 3

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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 (the electronic medical record software provider from which data were extracted), Leeds, United Kingdom. Gerald Liew: Financial support – RANZCO Eye Foundation/Novartis. Supported in part by the Department of Health's National Institute for Health Research Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital and the University College London Institute of Ophthalmology, London, United Kingdom. The views expressed in the publication are those of the authors and not necessarily those of the Department of Health. Supported in part by an unrestricted research award from Novartis Pharmaceuticals. No member or affiliate of Novartis had any input into data analysis, interpretation of the data or writing the manuscript. Javier Zarranz-Ventura is a grant recipient of the Spanish Retina & Vitreous Society (Sociedad Española de Retina y Vítreo).

    ∗

    Both authors (J.Z-V. and G.L.) contributed equally as first authors. A complete list of members of the United Kingdom Age-Related Macular Degeneration Electronic Medical Records Users Group is available at www.aaojournal.org.

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