Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-03-06

Brief Summary

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

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Detailed Description

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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

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Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No