Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT03010397
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief 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.

Study Timeline

• Study First Submitted: 2016-09-19
• Study Start: 2016-12
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Primary Completion: 2017-01-11
• Study Completion: 2019-03-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phenotypic classification of DR in a 5-year period	5 years	Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)

Secondary Outcome Measures

Name	Time	Method
DR severity level	5 years	ETDRS grading
Retinal thickness analysis	5 years	Retinal thickness (RT) in central subfield, inner and outer rings, assessed by SD-OCT and using layer-by-layer segmentation
Ellipsoid zone analysis	5 years	Degree of integrity of the ellipsoid zone, assessed by SD-OCT
Choroidal thickness analysis	5 years	Choroidal thickness assessed by Enhanced Depth Imaging (EDI) SD-OCT
SD- OCT- Angiography analysis	5 years	Vessel analysis, assessed by SD-OCT OCT-Angiography
OCT-Leakage analysis	5 years	LOR (low optical reflectivity) ratio in central subfield, inner and outer ring for assessment of BRB breakdown, assessed by OCT-Leakage
Retinal thickness quantification	5 years	Retinal nerve fiber layer thickness (RNFL) and ganglion cells layer (GCL) + inner plexiform layer thickness (IPL) thickness, assessed by layer-by-layer SD-OCT
mfERG assessement	5 years	P1 implicit time and P1 amplitude by ring

Trial Locations

Locations (1)

Aibili-Cec; 🇵🇹 Coimbra, Portugal