UK Age-Related Macular Degeneration Electronic Medical Record System (AMD EMR) Users Group Report IV: Incidence of Blindness and Sight Impairment in Ranibizumab-Treated Patients

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• 作者：Robert L. Johnston ; FRCOphth¹ ; ^&lowast ; ; Aaron Y. Lee ; MD ; MSCI² ; ³ ; ^&lowast ; ; ^{leeay@uw.edu" class="auth_mail" title="E-mail the corresponding author} ; Miranda Buckle ; MB BChir⁵ ; Richard Antcliff ; MD ; FRCOphth⁴ ; Clare Bailey ; MD ; FRCOphth⁵ ; Martin McKibbin ; FRCOphth⁶ ; Usha Chakravarthy ; MD ; PhD⁷ ; Adnan Tufail ; MD ; FRCOphth³ ; on behalf of the UK AMD EMR Users Group
• 关键词：AMD ; age-related macular degeneration ; ANCHOR ; Anti&ndash ; Vascular Endothelial Growth Factor Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration ; anti-VEGF ; inhibitor of vascular endothelial growth factor ; EMR ; electronic medical record system ; ETDRS ; Early Treatment Diabetic Retinopathy Study ; MARINA ; Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degenerati
• 刊名：Ophthalmology
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：123
• 期：11
• 页码：2386-2392
• 全文大小：500 K

文摘

To study the incidence of blindness and sight impairment in treatment-naive patients receiving ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD) in the United Kingdom (UK) National Health Service.

Design

Multicenter nAMD database study.

Participants

A total of 11 135 patients who collectively received 92 976 treatment episodes to 12 951 eyes.

Methods

Data were extracted from 14 UK centers using the same electronic medical record system (EMR). The EMR-mandated collection of a data set (defined before first data entry) including: age, Early Treatment Diabetic Retinopathy Study visual acuity letter score (VA) for both eyes at all visits, and injection episodes. Participating centers used overwhelmingly a pro re nata re-treatment posology at intended monthly follow-up visits following a loading phase of 3 monthly injections.

Main Outcome Measures

Incidence of blindness and sight impairment (VA in the better-seeing eye <38 letters [≤20/200 Snellen, approximately], and <68 letters [≤20/50 Snellen, approximately] at 2 consecutive visits, or 1 visit if no further follow-up data) in each year after initiating treatment.

Results

Information from >300 000 clinic visits (2.8 million data points) collected over 5 years was collated from 14 centers. Mean age at first treatment was 79.7 years (standard deviation = 9.19 years), with a female preponderance (63%). The mean (median) VA at baseline in the better-seeing eye was 67.2 (72.0) letters, 20/40− (20/40+) approximate Snellen conversion. The cumulative incidence of new blindness and sight impairment in patients with treated nAMD in at least 1 eye at years 1 to 4 after first injection were 5.1%, 8.6%, 12% and 15.6% for new blindness and 29.6%, 41.0%, 48.7%, and 53.7% for new sight impairment, but with significant reductions in the rates between year cohorts initiating treatment (blindness [P = 4.72 × 10⁻⁰⁸], sight impaired [P = 3.27 × 10⁻⁰⁶]).

Conclusions

To the best of our knowledge, this is the first multicenter real-world study on the incidence of blindness and sight impairment based on VA data in patients treated with ranibizumab for nAMD, and its results show low incidences of both blindness and sight impairment, which both declined during the study period.