Identifying progression of retinal disease in eyes with NPDR in diabetes type 2 using non‐invasive procedures. Protocol nº ECR‐RET‐2010‐02. ClinicalTrials.gov Identifier: NCT01145599

Abstract

AbstractPurpose To identify eyes that show worsening and disease progression (progressor phenotypes)Methods To identify Diabetic Retinopathy “progressors” to clinically significant retinal edema in type 2 diabetic patients with early NPDR, from baseline to the 12‐month visit, assessed by biomarkers. Primary Outcomes: Microaneurysms turnover computed from color fundus photographs using the RetmarkerDR software; Retinal thickness increase in the central subfield. Secondary Outcomes: BCVA changes; ETDRS step changes; and rescue treatment.Results Observational study with a follow‐up at 0, 3, 6 and 12 months in eyes with NPDR (≤35). Color fundus photographs analyzed with the RetmarkerDR software for automated assessment of microaneurysms turnover (MA formation and disappearance rate). Retinal thickness measured with Frequency Domain Optical Coherence Tomography (FD‐OCT).