NCT05581225

Prediction of Progression of Retinal Ischemia in Diabetes

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Association for Innovation and Biomedical Research on Light and Image · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: —

Summary

Diabetes Mellitus (DM) is a major public health problem with significant socioeconomic implications due to its increased prevalence. Diabetic retinopathy (DR) is the most frequent complication in DM patients and remains the leading cause of legal blindness in working-age populations (Yau et al., 2012). Differentiating patients with higher vs low risk of progression to vision-threatening complications is of paramount importance for an efficient managing of the disease to prevent vision disability. PREDICTION is a longitudinal prospective clinical study in DMT2 patients with a higher risk of progression to explore possible imaging, functional and systemic biomarkers of progression, using non-invasive methods, commonly applied in the clinical practice. Investigating the retinal vascular network (vessel density metrics with Optical Coherence Tomography Angiography) will allow a better understanding of the evolution of capillary closure and ischemia, two main risk factors for DR worsening.

Detailed description

Patients with Mild to Severe NPDR (ETDRS DRSS 43-53) often progress to PDR and/or CI-DME (ETDRS Report). However, it is unclear which patients in this group are likely to progress. Previous studies have shown that diabetic macular ischemia (DMI) is a risk factor for progression of DR. This study aims to correlate baseline OCTA metrics with visual function and identify risk factors for progression from NPDR to PDR and/or CI-DME.

Conditions

• Diabetic Retinopathy

Timeline

• Start date: 2022-12-02
• Primary completion: 2024-02-02
• Completion: 2028-10-31
• First posted: 2022-10-14
• Last updated: 2025-05-09

Locations

1 site across 1 country: Portugal