| Outcome Measures: |
Primary: Microaneurysm formation rate over 12 months, i.e. number of newly developed microaneurysms within 12 months, Weeks 27 and 52 | Secondary: Change in diabetic retinopathy stage (≥ 2 step change on ETDRS severity score), Weeks 27 and 52|Change in microaneurysm count, Weeks 27 and 52|Microaneurysm formation rate after 6 months (compared to baseline), after 6 months|Change in retinal thickness (as measured by Optical Coherence Tomography), Weeks 27 and 52|Change in retinal perfusion of microvasculature within the retina (flow in Optical Coherence Tomography Angiography), Weeks 27 and 52|Progression to clinically significant macular edema (CSME), Up to 52 weeks|Change in intraocular lipid content (hard exsudates), Weeks 27 and 52|Change in composite clinical outcome evaluating progression to proliferative diabetic retinopathy (PDR) based on photography, angiography plus clinically important events defining PDR (e.g. vitreous haemorrhage), Weeks 27 and 52|Change in best corrected visual acuity (BCVA [ETDRS letters]), Weeks 27 and 52|Change in HbA1c, Weeks 2, 7, 12, 17, 22, 27, 32, 37, 42, 47, 52 and 55|Change in fasting glucose, Weeks 2, 7, 12, 17, 22, 27, 32, 37, 42, 47, 52 and 55|Change in body weight and body fat mass, Weeks 27, 52 and 55|Change in ambulatory blood pressure, Weeks 27 and 52
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