Real-World Visual Outcomes of Treatment Naive Patients with Diabetic Macular Oedema
Aim: The aim of this audit was to determine whether patients with diabetic macular oedema attending a routine clinical practice were able to achieve and maintain the visual outcomes reported by clinical trials.
Methods: A retrospective observational study of 131 treatment-naive eyes of patients attending one suburban and one semi-rural ophthalmology clinic, in or close to Melbourne, Australia. Data were extracted from the Diabetic Macular Oedema module of the Fight Retinal Blindness! Registry1 from 2014 to 2020. Main outcome measures included diabetic retinopathy characteristics at baseline, pre-existing ocular conditions, previous treatments, current treatment given, visual acuity, and central subfield thickness.
Results: The average number of treatment injections was 5.58 in the first 12 months, compared with 5.51 beyond 36 months (p>0.05). Eighty percent of patients had a baseline visual acuity of better than 6/12 and there was a statistically significant improvement in acuity from baseline to Year 1, Year 2 and Year 3 (p<0.05). Baseline central serous thickness was 340.58μm and improved significantly at each time point (p<0.05).
Conclusion: Patients attending this routine clinical practice in the real world were not able to achieve and maintain the visual outcomes reported by the phase 3 clinical trials. This is most likely due to under-treatment and suggests that the dosing schedule for patients with diabetic macular oedema should be re-evaluated.