First Author: K.M.Darrad UK
Co Author(s): W. Fusi- Rubiano B. Gonglore A. Bhatnagar 0 0 0 0 0 0 0 0 0
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Ranibizumab was approved for treatment of centre-involving diabetic macular oedema (DMO) with central macular thickness (CMT) of 400 microns or more, in the National Health Service (NHS) in UK, in February 2013. We present our initial results (change in visual acuity and central macular thickness) in a real-life clinical setting.
A DMO service was set up to deliver intravitreal Ranibizumab theray in July 2013 in a secondary care hospital Eye department serving a population of nearly one million with over 26000 patients on the diabetes register. Patients meeting eligibility criteria as per NICE guidelines were treated in dedicated DMO clinics.
Patients with centre involving DMO and central macular thickness (CMT) of 400 microns or more were booked into dedicated clinics. Before initiating treatment, all patients had a logmar best corrected visual acuity (BCVA) assessment, comprehensive ophthalmic examination and optical coherence tomography (OCT) (Heidelberg Spectralis Spectral Domain OCT). All patients received an initial course of three intravitreal injections of Ranibizumab at monthly intervals. Subsequent monthly follow-ups were arranged with logmar BCVA and OCT scans being performed on every visit. Retreatment was carried out, if needed, on the same visit. Review of case-notes, data collection and analysis of all patients that had completed a minimum of four months follow-up from July 2013 to Feb 2014 was carried out.
72 eyes of 60 patients were followed up for a minimum of 4 months (range 4-7 months; mean 5.2 months). Mean BCVA at baseline = 52.2 letters (SD=15.4). Mean BCVA at the end of the follow-up period= 59.5 letters(SD=14.0). The change in BCVA (difference between best obtained vision after at least 4 months follow-up and the baseline vision was calculated for each eye. The mean change in BCVA was 8.2 letters (SD=10.2). 28 (38.9%) eyes gained 10 (23.6%) letters or more. 17 eyes gained 15 letters or more. None of the eyes lost more than 10 letters during this follow-up period. The mean central macular thickness at baseline was 547 microns (SD=145.4). This reduced to 382 microns (SD=127.58) at the last follow-up period. Three patients were excluded in the analysis due to unavailability of final CMT. The change in CMT was calculated for each eye and the mean reduction in CMT was 162 microns (SD=156.0). 20 eyes had final CMT of 300 microns or less. 10 eyes had CMT of 250 microns or less. Mean number of injections over the follow-up period was 4.4 (range = 3-6, Mode = 4)
In the published clinical trials, most of the visual gain occurs within the first 3-4 months of initiating treatment. Our early outcomes of intravitreal ranibizumab for DMO in a real-life clinical situation compare favourably with the results obtained in a tightly controlled environment of a prospectively conducted clinical trial. The number of injections in each eye in our group is less than the number of injections in published trials. This may be mainly due to some unintended extension of follow-up visits resulting in longer intervals between treatments. Studies with longer follow-up of treated patients would be necessary to determine if the initial success can be sustained in the long term.