DOI: 10.5061/dryad.pzgmsbcfw
title: Anti-vegf therapy in diabetic macular oedema patients over four years

description: OBJECTIVES: To evaluate visual acuity (VA) outcomes of intravitreal
 anti-vascular endothelial growth factor (VEGF) in diabetic macular oedema
 (DMO). METHODS: In this retrospective cohort study, electronic medical
 records for all patients undergoing intravitreal injections (IVI) in a
 tertiary referral centre between March 2013 and October 2018 were
 analysed. Treatment response in terms of visual acuity outcomes were
 reported for all eyes over a 4-year observation period. RESULTS: Our
 cohort includes 2614 DMO eyes of 1964 patients over 48 months. Cox
 proportional hazards modelling identified injection number (hazard ratio
 [HR] = 1.18), male gender (HR = 1.13), and baseline VA (HR = 1.09) as
 independent predictors to reach a favourable visual outcome of more than
 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Half of our
 cohort reached 70 letters 1.9 months after starting anti-VEGF therapy. Of
 those that reached 70 letters, 50% fell below 70 by 14.7 months.
 CONCLUSION: To date, this is the largest single centre cohort study and
 over the longest observation period reporting on real-life outcomes of
 anti-VEGF in DMO. We have made an anonymised version of our dataset
 available on an open-source data repository as a resource for clinical
 researchers globally.
description: <strong>Study setting and design:
 </strong>This study is a retrospective cohort study of diabetic
 patients treated for DMO by anti-VEGF  at a tertiary referral center -
 Moorfields Eye Hospital NHS Foundation Trust, London, UK. We obtained
 approval by the Institutional Review Board of the hospital (ROAD17/031) -
 Audit registration was completed (MEH-233). In this study, we complied
 with the Declaration of Helsinki and STROBE guidelines for the reporting
 of cohort studies. <b id="docs-internal-guid-61402e7d-7fff-ed44-5a2c-280842935454">Data source:</b> All clinical information at Moorfields Eye Hospital is recorded within an electronic medical record (EMR) application (OpenEyes Foundation, London, UK). A SQL database (SQL Server Reporting Service, Microsoft Corporation, Richmond, USA) containing all the information from the EMR is in place and regular updates are performed overnight to keep the data warehouse up-to-date. VA is reported in ETDRS letter score. The highest value (independent of measurement method) available at each visit was chosen.  <b id="docs-internal-guid-61402e7d-7fff-ed44-5a2c-280842935454">Participants: </b>A data-warehouse query for patients that received one IVI for DMO (between March 2013 and October 2018) resulted in 3226 unique eyes from 2368 patients. Exclusion criteria were those that: (i) suffered from macular oedema secondary to other conditions than diabetes; (ii) under 18 years old; (iii) received fewer than 3 IVI; (iv) received bevacizumab, dexamethasone intravitreal implant, or fluocinolone acetonide intravitreal implant; leaving 2614 eyes of 1964 patients taken forward for analysis.  
description: anon_id 
 Deidentified patient identification number<br>
 String eye Laterality of eye.<br> String,
 categorial<br>  (r = right, l =left) 
 follow_up_days 
 Days
 following baseline i.e. injection number 1<br> Number,
 integer<br> 0, xx, xxx, ... 
 baseline_age 
 Age at baseline i.e. injection number
 1<br> Number, categorical<br> (20-30 = [20,30],<br>
 31-40= [31,40],<br> 41-45 = [41,50],<br> 51-55 =
 [51,60],<br> 61-65 = [61,70],<br> 71-75 = [71,80],<br>
 81-100= [81,100]) 
 ethnicity String, categorical
 (Asian or Asian British, White,
 Black or Black British, Mixed,
 Other ethnic group, Unknown)
 
 gender Gender<br> String,
 categorical<br> (m = male, f = female) 
 
 va Visual acuity in ETDRS (early treatment
 diabetic retinopathy study) letters<br> Number, integer
 
 baseline_va Visual acuity in ETDRS (early treatment
 diabetic retinopathy study) letters at baseline i.e. injection number
 1<br> Number, integer 
 
 inj_num Injection number<br> Number,
 integer 
 inj_given Injection given or not<br>
 String, categorical<br> (y = Yes, n = no)