Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes

Association for Innovation and Biomedical Research on Light and Image212 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

212

Conditions

Diabetic Retinopathy

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Aibili-Cec

Coimbra, Portugal

Outcomes

Primary Outcomes

Phenotypic classification of DR in a 5-year period

Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)

Time frame: 5 years

Secondary Outcomes

DR severity level

ETDRS grading

Time frame: 5 years

Retinal thickness analysis

Retinal thickness (RT) in central subfield, inner and outer rings, assessed by SD-OCT and using layer-by-layer segmentation

Time frame: 5 years

Ellipsoid zone analysis

Degree of integrity of the ellipsoid zone, assessed by SD-OCT

Time frame: 5 years

Choroidal thickness analysis

Choroidal thickness assessed by Enhanced Depth Imaging (EDI) SD-OCT

Time frame: 5 years

SD- OCT- Angiography analysis

Vessel analysis, assessed by SD-OCT OCT-Angiography

Time frame: 5 years

OCT-Leakage analysis

LOR (low optical reflectivity) ratio in central subfield, inner and outer ring for assessment of BRB breakdown, assessed by OCT-Leakage

Time frame: 5 years

Retinal thickness quantification

Retinal nerve fiber layer thickness (RNFL) and ganglion cells layer (GCL) + inner plexiform layer thickness (IPL) thickness, assessed by layer-by-layer SD-OCT

Time frame: 5 years

Data from ClinicalTrials.gov

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