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

Association for Innovation and Biomedical Research on Light and Image

Status: Completed

Conditions: Diabetic Retinopathy

Study type: Observational

Funder types: Other

Identifiers

NCT03010397

IPM-2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 212 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus according to 1985 WHO criteria
• Aged between 35 years and 80 at baseline in the retrospective period
• NPDR level < 20 (MA absent) or Mild NPDR (levels 20 to 35, based on ETDRS criteria- 7 fields CFP) at baseline
• BCVA ≥ 75 letters (≥ 20/32) at baseline (ETDRS charts)
• Informed Consent

Exclusion criteria

• Inadequate ocular media and/ or pupil dilatation that interfere with fundus examinations
• HbA1C > 10 % at the Screening or previous 6 months in the previous prospective study