NCT03010397

Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes

PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 212 (estimated)
• Sponsor: Association for Innovation and Biomedical Research on Light and Image · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes (PROGRESS)

Detailed description

The global aim of this study is to improve the current knowledge of diabetic retinopathy (DR) progression. We aim to characterize both functionally and morphologically initial DR stages and to identify patients at risk of progression to centre involving macular oedema (CME) and/or proliferative diabetic retinopathy (PDR). We want to identify imaging patterns and characteristics that might be used as prognostic biomarkers for DR progression. For this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive retinal imaging methodologies. SD-OCT with layer-by-layer segmentation will be performed. Furthermore, a state-of-the-art methodology with OCT-Angiography will be used for identification of areas of capillary drop-out and leakage areas will be identified on SD-OCT without the need of a dye injection. In a subgroup of patients we will study neurodegeneration patterns using multifocal ERG examination.

Conditions

• Diabetic Retinopathy

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-01-11
• Completion: 2019-03-06
• First posted: 2017-01-05
• Last updated: 2020-03-24

Locations

1 site across 1 country: Portugal