Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Recruiting · NCT07458516 · Observational (researchers observe without assigning treatment) · Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
- Non-proliferative diabetic retinopathy (NPDR; DRSS levels 43, 47, 53) or mild proliferative diabetic retinopathy (PDR; DRSS level 61: Neovascularization Elsewhere (NVE) \< ½ disc area in ≥ 1 quadrant, no Neovascularization of the Disc (NVD), no vitreous or sub-hyaloid hemorrhage), in which panretinal photocoagulation (PRP) and/or intravitreal anti-VEGF treatment can safely be deferred for at least 6 months, based on consensus between patient and investigator - using ETDRS criteria, 7-field equivalent area on ultra-widefield fundus imaging.
- Ability to understand and sign the written Informed Consent Form (ICF).
Exclusion criteria
- 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.
- Other retinal vascular diseases (ocular ischemic syndrome, retinal arterial or venous occlusion, exudative age-related macular degeneration, etc.).
- Previous panretinal photocoagulation (PRP) or intravitreal injection treatment.
- Any eye surgery within 6 months prior to the inclusion visit.
- Significant media opacities including severe cataract, corneal scarring or edema, or vitreous hemorrhage that precludes fundus evaluation.
- Pupil dilation \< 5 mm.
Where it is running
1 location listed.
- AIBILI-CEC (AIBILI-Clinical Trial Centre) - Coimbra, Portugal