First Author: R.Healy UK
Co Author(s): F. Alkherdahji A. Salam Q. Mohamed E. Fletcher R. Johnston 0 0 0 0 0 0 0 0 0
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To analyse the change in visual acuity and macular thickness in patients treated with intravitreal ranibizumab for centre-involving diabetic macular oedema (CIDMO)
Paperless clinic using an Electronic Medical Record (EMR) for patients with CIDMO, Gloucestershire Hospitals NHS Foundation Trust
Data were prospectively collected using an electronic medical record (EMR), which enforces standardised recording of the minimum signs necessary to automatically calculate an Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy and maculopathy grade. All the clinicians work to a standardised re-treatment protocol (simplified version of the DRCRnet protocol). All patients with a minimum potential 3 months of follow up following first intravitreal injection of ranibizumab for centre-involving diabetic macular oedema were included in this study. All patients had three initial treatments of ranibizumab with 4-6 weekly follow up and pro re nata retreatment according to the protocol. Visual acuities were recorded using 4m ETDRS logMAR charts. Central 1mm retinal thickness (CRT) was measured using optical coherence tomography (OCT) and were extracted from the EMR.
123 eyes of 95 patients, with a median age of 66 years at the time of the first injection were analysed. The female: male ratio was 1:2. At baseline the median visual acuity was 55 letters (123 eyes), improving to 61 letters (110 eyes, P = 0.026) at 3 months, 62 letters (90 eyes, P = 0.001) at 6 months and 69 letters (29 eyes, P<0.001) at 12 months. The proportion of eyes gaining >15 letters or more at 3, 6 and 12 months were 10.0%, 21.1% and 31.0% respectively and the percentage of eyes with 70 letters or more at these time points were 32%, 33% and 48% respectively. For the 90 and 29 eyes completing 6 and 12 month follow up respectively the median number of injections were 4 and 6 respectively. Median CRT was 456 µm at baseline, reducing to 336 µm at three months (P<0.001), 349 µm at 6 months (P<0.001) and 309 µm at 12 months (P<0.001).
This study suggests that the benefits of ranibizumab for centre-involving diabetic macular oedema that were proven in randomised controlled clinical trials translate into real-world clinical care. In this real-world study the VA improvements matched the results of the pivotal trials with a similar proportion of eyes achieving a VA of 70 letters or more at 1 year.