Real-world outcomes of Ranibizumab treatment for Diabetic Macular Oedema

Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Conclusions: 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.