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Namritha Valerie Patrao, Sheelah Antao, Dawn A Sim, Sobha Sivaprasad, Richard Andrews, Robin Hamilton, Catherine A Egan, Adnan Tufail, Philip G Hykin, Ranjan Rajendram; Real-world outcomes of Ranibizumab treatment for Diabetic Macular Oedema. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3148.
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To evaluate real-world visual acuity (VA), clinical and Spectral Domain Optical Coherent Tomography (OCT) outcomes of intravitreal Ranibizumab therapy for Diabetic Macular Oedema (DMO) in a National Health Service (NHS) population.
225 eyes of 178 patients diagnosed with centre-involving DMO and VA ≤ 79 ETDRS letters with central retinal thickness (CRT) ≥400µm on OCT and a foveal avascular zone greatest linear diameter ≤1500um on fundus fluorescein angiography initiated on a loading phase of 3 intravitreal Ranibizumab injections and who had at least 6 months follow up were reviewed. The treatment regimen subsequently included monthly reviews and PRN retreatment.<br /> <br /> Baseline characteristics, VA, number of injections, OCT central retinal thickness (CRT) and macular volume (MV) were recorded at baseline and monthly to 6 months.
The mean age of the cohort was 64.9 (SD 11.2) years with 64% males and 36% females. 96% had Type 2 and 4% had Type 1 diabetes mellitus. 68% had prior macular laser and 36% had prior panretinal photocoagulation laser. 47(28%) patients had bilateral injections. Mean baseline VA was 56 (SD 15.2) letters, OCT CRT was 449.2µm (SD 134.3) and MV was 10.2 mm3 (SD 2.2).<br /> <br /> The mean change in VA at 6 months was +5.9 letters (SD 11.9). 30% of eyes showed an increase of ≥10 and 19% ≥15 ETDRS letters. The CRT decreased by 112.1um (SD 158.9) and the MV reduced by 1.41mm3 (SD 2.1). The patients received an average of 5.2 (SD 1.2) injections at 6 months.<br /> There were no cases of endophthalmitis following 1159 injections given during the study period.
Despite this patient group only receiving therapy following UK NHS NICE approval of Ranibizumab for DMO, the data suggests that Ranibizumab therapy in a routine clinical care setting can approach the outcomes of landmark clinical trials.
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