The purpose of this clinical study is to explore imaging, functional and systemic biomarkers of diabetic retinopathy (DR) progression, in Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss.
Type 2 diabetes mellitus (T2D) according to 1985 World Health Organization (WHO) criteria.
Age between 35 and 80 years.
Best-corrected visual acuity (BCVA) ≥ 69 letters (20/40).
Refraction with a spherical equivalent less than 5 diopters.
Central subfield thickness (CST) > 400 μm (fluid allowed if CST ≤ 400 μm and foveal contour is normal, as determined by the Central Reading Centre, and treatment is not immediately required).
Any sign of retinal fibrovascular proliferation.
Uncontrolled glaucoma (intraocular pressure > 25 mmHg regardless of concomitant IOP-lowering medications) or neovascular glaucoma.
Any sign of iris neovascularization, vitreous, or pre-retinal hemorrhage.
Study Population: Patients with moderate to severe NPDR and mild PDR. Ideally, the distribution of participants will be as follows: 40 for Diabetic Retinopathy Severity Scale (DRSS) level 43, 40 for DRSS level 47, and 20 for DRSS levels 53-61
Cohort
Prospective
Not listed
Changes in capillary skeletonized vessel density (SVD)
Evaluate baseline differences and longitudinal changes (from baseline to month 24) in capillary non-perfusion using skeletonized vessel density (SVD) in the superficial and deep retinal vascular layers assessed with Optical Coherence Tomography Angiography.
Changes in capillary perfusion density (PD) using OCTA
Evaluate baseline differences and longitudinal changes (from baseline to month 24) in capillary non-perfusion using binarized vessel density (VD) as perfusion density (PD) in the superficial and deep retinal vascular layers assessed with Optical Coherence Tomography Angiography.
Foveal Avascular Zone (FAZ) area
Evaluate baseline differences and longitudinal changes (from baseline to month 24) in the area of the foveal avascular zone measured in square millimeters (mm²) using Optical Coherence Tomography Angiography automated segmentation tools across DRSS levels.
Foveal Avascular Zone (FAZ) perimeter
Evaluate baseline differences and longitudinal changes (from baseline to month 24) in the perimeter of the foveal avascular zone measured in millimeters (mm) using Optical Coherence Tomography Angiography automated segmentation tools across DRSS levels.
Changes in DRSS levels
Evaluate baseline differences and longitudinal changes (from baseline to month 24) in DRSS classification, including one-step and two-step changes across DRSS levels.
Changes in Best Corrected Visual Acuity (BCVA)
Evaluate baseline differences and longitudinal changes (from baseline to month 24) in BCVA, measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Retinal sensitivity using MAIA Microperimetry
Evaluate baseline differences and longitudinal changes (from baseline to month 24) in average macular sensitivity (dB), fixation indices P1 and P2 (%), and Bivariate Contour Ellipse Area (BCEA; 63% and 95%) across DRSS levels.
Changes in Intraretinal Microvascular Abnormalities (IRMAs)
Evaluate baseline differences and longitudinal changes (from baseline to month 24) in presence and area of IRMAs using Swept-Source-OCTA and FFA, including location-specific analysis across posterior pole and mid-periphery across DRSS levels.
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Association for Innovation and Biomedical Research on Light and Image
Lead sponsor
Fundação para a Ciência e a Tecnologia
Collaborator
