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.
Association for Innovation and Biomedical Research on Light and Image
Lead sponsor
Fundação para a Ciência e a Tecnologia
Collaborator